WO2009019689A2

WO2009019689A2 - Tumor screening system and methods thereof

Info

Publication number: WO2009019689A2
Application number: PCT/IL2008/001071
Authority: WO
Inventors: Eitan Weintraub; Yoram Eshel; David Weintraub
Original assignee: Cascades Ltd.
Priority date: 2007-08-06
Filing date: 2008-08-05
Publication date: 2009-02-12
Also published as: WO2009019689A3

Abstract

The aim of the present invention is to provide a novel tumor screening system and method based on a differentiating complex adapted for differentiating in-vivo a tumor from normal tissue; an intracorporeal detecting unit adapted for detecting in-vivo at least one physical signal functionally associated with said differentiating complex; an intracorporeal transmitting unit adapted for transmitting at least one signal correlated with said physical signal to an extracorporeal receiving device; and an extracorporeal receiving device adapted for receiving and storing said transmitted signal.

Description

TUMOR SCREENING SYSTEM AND METHODS THEREOF

FIELD OF THE INVENTION

The present invention relates to in-vivo tumor screening in general, and to in-vivo tumor screening in the gastro intestinal tract, the gastro intestinal tract ancillaries and the prostate in particular.

BACKGROUND OF THE INVENTION General

Cancer is a major cause of illness and death worldwide. In the United States about half a million people die of cancer each year. An estimated 3 to 35 percent of all cancer deaths could be avoided through early detection with screening (http://www.baptistonline.org/health/librarv/canc4276.asp).

The gastrointestinal (Gl) tract is a site of more malignant tumors than any other organ system in the human body, which is one reason that much is known about genes that predispose to Gl cancers (Boland & Meltzer, 2008). The incidence of cancer in each organ of the gastrointestinal tract varies enormously around the world (Parkin et al., 1993). The wide variations seen among different national groups appear to be explained almost entirely by environmental factors, principally dietary influences and the effects of chronic infections with different bacteria or viruses.

Colorectal Cancer

Colorectal cancer (CRC) has become a major healthcare concern. More than one million new cases are diagnosed yearly worldwide. CRC is the second leading cause of cancer death with an estimated yearly worldwide death toll of 510,000 people. The life time risk of contracting CRC is estimated as 0.6%. CRC is preventable through early detection, chemo- prevention and change in life style and nutrition. Since the beginning of the 21 century, there is a growing global awareness to the necessity of screening CRC in certain population. Consequently, legislation was passed in both the USA (2001) and Germany (2002) and more recently in Italy and France, to ensure healthcare provider coverage for screening colonoscopy for patients over the age of 50. As a result there is a dramatic increase in the number of colonoscopies performed and those in demand.

Currently, the screening options for CRC include: fecal occult blood test (FOBT, http://www.webmd.com/colorectal-cancer/fecal-occult-blood-test-fobt) flexible sigmoidoscopy, and colonoscopy (http://www.webmd.com/colorectal- cancer/guide/colonoscopy-what-vou-need-know). These methods are a major barrier to the achievement of optimal results. Several new screening modalities, such as the computerized tomographic colonography (CTC or virtual colonoscopy or virtual colonography) and stool DNA testing have recently been developed.

In spite of the new procedures developed to date, Colonoscopy remains the gold standard for colorectal screening, as it provides very high sensitivity (90%<) with a false negative rate of 6% for adenomas 1 cm or more in diameter.

In a recent study that published by scientists from the Center for Disease Control (CDC) it was reported that 14.2 million colonoscopies were performed in the USA in 2002 and half of those were screening colonoscopy procedures. In addition 2.8 million sigmoidoscopies were performed. The same investigators estimated that there are 42 million Americans over the age of 50 who have not been screened and that if colonoscopy will be used as the screening method it would take 10 years to screen the unscreened population. There are approximately 9,000 gastroenterologists who perform colonoscopy in the USA. It has recently been estimated that there is a need for 32,700 more gastroenterologists to meet market demand.

As one can see all screening modalities available to date are based on visual inspection of the colon, and as such, the colon should be empty from all content. Therefore, the preparation period is very unpleasant and intimidating and the visual inspection itself can create false negative results in cases were the malignant polyp is in a hidden part of the colonoscopy trajectory. In addition, the available procedures are very inconvenient and traumatic to the patient. Thus, there is a huge need for a screening method that will not require cleaning the content of the colon that will be more convenient and friendly to the patient, and will not be based on visual inspection that requires expensive and awkward equipment.

Small intestine Cancer

Small bowel cancer is a rare cancer that comprises only 1 % to 2% of all gastrointestinal cancers. There is no screening test for bowel cancer at present.

Esophageal cancer

Esophageal cancer is cancer of the esophagus, the hollow muscular tube that carries food and liquid from your throat to your stomach to be digested. About 13,000 people in the United States are diagnosed with esophageal cancer each year. The incidence of esophageal cancer is rising in the United States, particularly in the form of the disease called adenocarcinoma. Available screening tests to date are gastroscopy with tissue biopsy and screening is by the PillCam ESO by Given Imaging. The main disadvantages of the available methodologies are esophageal damage, sedation complications and intestinal obstructions.

Prostate

Eighty-five percent of all prostate cancers are discovered in the local and regional stages; the 5-year relative survival rate for patients whose tumors are diagnosed at these stages is 100%. Screening tests available today include Digital Rectal Exam (DRE), Trans-rectal ultrasound and Prostate Specific Antigen Test (PSA). The sensitivity of DRE alone is very poor (2.2-25%), the trans-rectal ultrasound is highly discomfort to the patient and the PSA is not exclusive to cancer as a high level of the antigen may also indicate prostate infection, inflammation, enlargement or cancer.

Antibodies

Antibodies are immune system-related proteins called immune-globulins.

Each antibody consists of four polypeptides- two heavy chains and two light chains joined to form a "Y" shaped molecule. The amino acid sequence in the tips of the "Y" varies greatly among different antibodies. This variable region gives the antibody its specificity for binding antigen. Tumor cells usually comprise tumor specific antigens, i.e. proteins or other molecules that are unique to cancer cells or much more abundant in them. These molecules are potential targets for immunotherapy or other types of anticancer treatment and screening.

RFID Technology

Radio frequency identification (RFID) technology has been around for more than 50 years, improving business productivity and enhancing the safety and security of millions of people. Door and building access control, theft prevention, toll-road payment systems, and inventory management are just a few of the applications in use today.

RFID's components include a transponder which contains information and a reader which recognizes the transponder and can access the information it contains. An RFID transponder or tag can be passive or active. A passive RFID tag can only transmit when it comes within a range of an RFID reader. Passive

RFID tags do not have their own power source but require energy from the reader to power up. Active RFID tags contain a battery and can send data without being powered by the reader. RFID can operate at different frequencies for different usages. For example, 125/134 kHz is adequate for read-only usages such as access control, while 13.56 MHz is used for read/write applications, like mass transit value debit or cashless vending.

RFIDs can be made of tiny electric circuit units (Kodak patent application 20070008113 and Hitachi powder RFID (www.pinktentacle.com/2007/02/hitachi- develops-rf id-powder). The Hitachi "powder" type RFID chip is a material measuring 0.05 x 0.05 mm are the smallest known yet. RFIDs may also be made of chip-less RF tags as described in details in http://crossid.innovva.com/ and http://www.microtaq-temed.com/. Such technology addresses the ability to provide printable (liquid) automatic identification technology similar in application to Bar Code technology, but using radio frequency and resonances signals instead of optical signals.

NQR Technology

Nuclear quadrupole resonance (NQR) is a technique related to nuclear magnetic resonance (NMR) which is used to detect atoms whose nuclei have a nuclear quadrupole moment. NQR uses a radiofrequency coil that produces an oscillating field at a frequency identified with a specific compound containing one or more quadrupole nuclei for its activation. NQR detection systems usually use non-ionizing magnetic fields near 5MHz₁ and therefore present no health hazards to living organisms or tissues. Thus, this technology can be used to identify biological targets as disclosed in US7148684B2, by attaching the NQR material to an adequate carrier.

Nano Particles in diagnostic

The use of nanoparticles for tumor tissues targeting is know in the art and described in details by Brigger et at., 2002, "Nanoparticles in cancer therapy and diagnosis", Advanced Drug Delivery Reviews 54 (2002) 631-651, incorporated herein by reference. Due to unique patho-physiological characteristics of most solid tumors that are not observed in normal tissue or organs, such as extensive angiogenesis and hence hypervasculature, defective vascular architecture, impaired lymphatic drainage, and greatly increased production of number of permeability mediators. These specific features together with the small size and the shape of nanoparticles lead to enhanced accumulation of various materials, including nanoparticles, in tumors. The amount of nanoparticles accumulated in a tumor may be further increase by coating or attaching to the nanoparticle a substance such as folic acid (see: Kukowska-Latallo et al., Cancer Res 2005; 65: (12). June 15, 2005; Praetorius & Mandal, 1872-2113/07, Bentham Science Publishers Ltd. 2007).

The use of nano particles in the diagnostic field is well established in the art. US 2006/0140871 disclose a paramagnetic or super paramagnetic nano particle ligand that includes a recognition ligand that interacts with a component on the surface of the prostate cancer cell. US 2006/0222594 disclose a targeting magnetic nanosphere preparation capable of diagnosing and treating tumors in mammals and method of manufacturing the same. The smart magnetic nanosphere preparation contains magnetic nano-sized iron oxide nano particles, which can be detected by magnetic resonance imaging (MRI). The major drawback of the disclosed technique is the fact that the diagnosis itself is conducted by known imaging techniques that require expensive and awkward equipment. US2005266090 provides biocompatible, low molecular weight nano particulate formulations that are designed to retain and deliver therapeutics over an extended time course. The detection is carried out by conventional awkward equipment such as MRI. WO20Q4083902 provides multifunctional magnetic nano particle probe compositions for molecular imaging and monitoring, comprising a nucleic acid or polypeptide probe, a delivery ligand, and a magnetic nano particle having a biocompatible coating thereon. In particular, the nucleic acid or polypeptide probes bind to a target and generate an interaction observable with magnetic resonance imaging (MRI) or optical imaging. As all other inventions disclosed above, the observation itself still involve awkward equipment such as MRI. Thus, there is a huge need for a screening system and methodology that are simple, relatively cheap, friendly to the patient and do not require awkward equipment. The present invention provides such a solution.

SUMMARY OF THE INVENTION

It is the aim of the present invention to provide a tumor screening system comprising: A differentiating complex adapted for differentiating in-vivo a tumor from normal tissue; An intracorporeal detecting unit adapted for detecting in-vivo at least one physical signal functionally associated with said differentiating complex; An intracorporeal transmitting unit adapted for transmitting at least one signal correlated with said physical signal to an extracorporeal receiving device; and An extracorporeal receiving device adapted for receiving and storing said transmitted signal.

In accordance with preferred embodiments of the invention, at least the intracorporeal detecting unit and the intracorporeal transmitting unit are arranged in housing in a form of a pill or a suppository, designated hereafter: "GiPiII" that is adapted to be introduced to a subject intracavitary.

Another aim of the present invention is to provide a method for tumor screening in a subject, said method comprising the steps of: a. Differentiating in vivo a tumor from normal tissue by a differentiating complex; b. Detecting in vivo at least one physical signal functionally associated with said differentiating complex by an intracorporeal detecting unit; c. Transmitting at least one signal correlated with said physical signal to an extracorporeal receiving device by an intracorporeal transmitting unit; and d. Receiving and storing said transmitted signal by an extracorporeal receiving device.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the appended figures. Identical structures, elements or parts that appear in more than one figure are generally labeled with a same numeral in all the figures in which they appear. Dimensions of components and features are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. It is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. The figures are listed below: Figure 1 is a schematic illustration of a subject undergoing a tumor screening procedure with a tumor screening system in accordance with preferred embodiment of the invention.

Figure 2 is a schematic illustration of six embodiments of a differentiating complex according to the present invention. 2A illustrates an immunological detection complex; 2B and 2C illustrate a metabolic detection complex; 2D illustrates a magnetic nanoparticle; 2E illustrates a nanoparticle containing RFIDs or NQRs inside of it; and 2F illustrates a nanoparticle covered by a RFIDs or NQRs on its surface.

Figure 3 is a schematic illustration of possible intrinsic properties of a differentiating complex according to various embodiments of the invention. Fig. 3A illustrated a magnetic differentiating complex; 3B illustrates an electromagnetic differentiating complex; 3C illustrates a radioactive differentiating complex.

Figure 4 is a schematic illustration of a Gastro Intestinal Pill (hereinafter: "GiPiII") in accordance with preferred embodiments of the invention. Figure 4A illustrates a basic structure of a passive GiPiII 3OA adapted to detect either a magnetic or a radioactive differentiating complex according to a preferred embodiment of the invention; Figure 4B illustrates a basic structure of an active GiPiII 3OB adapted to detect a magnetic differentiating complex according to another preferred embodiment of the invention or to detect a differentiating complex that comprises RFIDs or NQRs ; Figure 4C illustrates another optional structure of an active GiPiII 3OC adapted to detect RFID or NQR differentiating complex according to one another preferred embodiment of the invention.

Figure 5 is a schematic illustration of a basic structure of an extra corporeal receiving device (hereinafter: "ERD") 40 in accordance with preferred embodiment of the invention.

Figure 6 is a schematic illustration of a GiPiII 30 detecting a tumor while traveling in the gastro intestinal tract (hereinafter: "Gl tract") according to preferred embodiments of the invention. Figures 6a - 6c illustrate RFID or NQR based screening system. Fig. 6a illustrates differentiating complex comprising RFIDs or NQRs accumulated in a tumor located in the gastro intestinal tract following intravascular administration of the differentiating complex to a subject; Fig. 6b illustrates differentiating complex attached to the surface of a tumor located in the gastro intestinal tract following intracavitary administration of the differentiating complex to a subject; Fig. 6c illustrates a differentiating complex accumulated in a tumor located outside the gastro intestinal tract in one of the gastro intestinal ancillaries or in the prostate following intravascular administration of the differentiating complex to the subject. Figures 6d-6f illustrate a magnetic based screening system. Fig. 6d illustrates differentiating complex accumulated in a tumor located in the gastro intestinal tract; Fig. 6e illustrates differentiating complex attached to the surface of a tumor located in the gastro intestinal tract; Fig. 6f illustrates a differentiating complex accumulated in a tumor located outside the gastro intestinal tract. Figures 6g-6i illustrate a radioactive emission based screening system in which the differentiating complex is accumulated in a tumor located inside the gastro intestinal tract (Fig. 6g), attached to the surface of a tumor located in the gastro intestinal tract (Fig.θh), and accumulated in a tumor located outside the gastro intestinal tract (Fig. 6i).

DETAILED DESCRIPTION OF THE INVENTION The present invention is aimed to provide a novel system for screening tumors in the gastro intestinal tract, its ancillaries and in the prostate.

The term "tumor" as used herein includes every abnormal swelling and growth of tissue of every part of the gastro intestinal tract, its ancillaries and the prostate, and includes a benign tumor, a polyp, a dysplastic tumor, a premalignant tumor, a malignant tumor, and a cancerous tissue.

The digestive system in humans includes the gastrointestinal (Gl) tract and its ancillaries. For the purposes of the present invention, the term "Gl tract and its ancillaries" includes the following segments and organs: Mouth, Oropharynx, Esophagus, Stomach, Small intestine (Duodenum, Jejunum, and Ileum), Large intestine (Cecum and Colon), Rectum, Anal canal, Salivary glands (Parotid, Submandibular, and Sublingual), Tongue, Teeth, Liver, Gallbladder, Pancreas, and Vermiform appendix.

In accordance with preferred embodiment of the present invention the tumor screening system comprises: a. A differentiating complex adapted for differentiating in-vivo a tumor from normal tissue; b. An intracorporeal detecting unit adapted for detecting in-vivo at least one physical signal functionally associated with said differentiating complex; c. An intracorporeal transmitting unit adapted for transmitting at least one signal correlated with said physical signal to an extracorporeal receiving device; and d. An extracorporeal receiving device adapted for receiving and storing said transmitted signal.

Optionally, the tumor screening system of the invention further comprising an analyzing unit adapted for identifying a signal that is different from a predefined noise signal by amplitude, frequency, form and combinations thereof, to thereby allow indicating the existence of a tumor. The term "differentiating complex" as used herein includes any complex, material, substance or component that is capable of differentiating a tumor from normal tissue either directly or indirectly. The differentiation capabilities of the differentiating complex may be because of inherent characteristics of components comprised in the differentiating complex such as tumor specific antibodies that recognize specific tumor antigens, or it can be because of high affinity of at least one component comprised in the differentiating complex to tumorigenic tissue due to the unique characters of the tumor. Examples of such components are metabolites, vitamins such as folic acid and nanoparticles.

The differentiating complex of the invention comprises at least one component or substance that allows detection of the differentiating complex by the intracorporeal detection unit. Exemplary embodiments of such components and combinations thereof are illustrated in Figure 2.

Reference is now made to Figure 1 , which schematically illustrates a subject undergoing a tumor screening procedure with a tumor screening system in accordance with one embodiment of the invention. Following injection or swallow of a magnetic differentiating complex 44 the differentiating complex accumulates in a tumorigenic tissue in the Gl tract 52 of a subject. After a predetermined period of time that allows the distribution of the differentiating complex in the subject's body, the subject swallows a GiPiII 30. The GiPiIl 30 comprises at least the intracorporeal detecting unit and the intracorporeal transmitting unit, and it travels in the Gl tract and detects, while passing near a tumor, a magnetic field 32 that is created by the magnetic differentiating complex 44 that accumulated in or around the tumor. The signal obtained from the differentiating complex 44 is translated to another signal 27 and transmitted to an extracorporeal receiving device (ERD) 40 to thereby indicate the detection of a tumor.

Figure 2 illustrates various embodiments of a differentiating complex in accordance with preferred embodiments of the present invention. The differentiating complex can be administered to a subject in two major routes: intravenously or intracavitary. The differentiating complex comprises at least one of an immunological differentiating complex 20, a metabolic differentiating complex 22, a nanoparticle 23, a polarized substance (not shown), a radio frequency identification material 33, a nuclear quadrupole resonance material, a bioactive agent, and combinations thereof. The immunological and/or metabolic character of the differentiating complex provides the differentiating complex its ability to differentiate tumors from normal healthy cells. Such ability is also attributed to nanoparticles that tend to target themselves toward tumorigenic tissue. Optionally, the polarized substance is a polarized metabolite that is capable of creating or modifying an electric field, a magnetic field, an electromagnetic field and combinations thereof.

In accordance with the screening system provided herein, upon approximation of the intracorporeal detecting unit to the differentiating complex, the differentiating complex either creates or modifies at least one of a detectable: magnetic field, electric field, electromagnetic field, and combinations thereof. Optionally or alternatively, the differentiating complex emits radioactive radiation that is detected by the intracorporeal detecting unit upon approximation to said differentiating complex. In accordance with embodiments of the invention the nanoparticle can be a nanosphere, a nanocapsule and combinations thereof. The nanoparticle may be coated with a magnetic layer or comprise a magnetic core or alternatively may be coated or comprise a metallic material susceptible to magnetic field. Alternatively or additionally, the nanoparticle may be coated with a metabolic layer such as folic acid that is known by its high affinity to tumors, or it may comprise or attached to a Tumor Necrosis Factor (TNF) that is capable of selectively entering and attaching tumor cells such as Trail.

Figure 2A illustrates an immunological differentiating complex 20 that comprises a core 1 covered by or attached to at least one layer comprising at least one type of tumor specific antibodies 3. In the embodiment shown in figure 2A the core 1 is coated by an intermediate layer 2, preferably a protein layer, which is coated by an outer layer that comprises at least one type of tumor specific antibodies 3. The core 1 may also be attached to an intermediate substance that is attached to or covered by at least one type of tumor specific antibodies (not shown). In one another embodiment, the core 1 is covered by or attached directly to an outer layer that comprises at least one type of tumor specific antibodies 3 with no intermediate layer or substance between them. The tumor specific antibodies can be either one of: Gl tract tumor specific antibodies, Gl tract ancillary tumor specific antibodies, prostate specific antibodies, and a mixture thereof, and are capable of providing indication about the existence or non existence of a tumor in the Gl tract, its ancillaries and the prostate according to the antibodies that are used. In one embodiment of the invention, the immunological differentiating complex

20 comprises a labeled substance. The labeling may be any type of molecular labeling that is know in the art and is suitable for the purposes of the tumor screening system of the invention including without limitation, radioactive labeling, magnetic labeling, electromagnetic labeling, nuclear quadruple resonance labeling and others.

When using an immunological differentiating complex, the screening system of the invention may be used for screening a specific organ or for screening numerous organs simultaneously. The screening extent is determined according to the type of antibodies being comprised in the immunological differentiating complex i.e. one type of antibodies (e.g. colon specific antibodies, esophagus specific antibodies, pancreas specific antibodies, prostate specific antibodies, etc.), or a mixture of antibodies that recognize various organs of the Gl tract, its ancillaries and the prostate.

The core 1 of both, the immunological differentiating complex (Fig.2A) and the metabolic differentiating complex (Fig.2B; Fig. 2C), or the nanoparticle (Fig. 2D-

2F), may have various characteristics. For example, the core 1 or the nanoparticle may be susceptible to magnetic or electric fields, or to both. In such an embodiment, the core or the nanoparticle may comprise materials like Iron,

Cobalt, Nickel and the like that change their spatial configuration due to the presence of an electromagnetic field and as a result can create a macroscopic detectable magnetic or electric field. In one another embodiment, the core 1 or the nanoparticle 23 has its own magnetic field.

In a further embodiment of the invention, the core 1, or the nanoparticle 23 has radioactive properties and comprise or attached to materials that are used in nuclear medicine while performing radioactive scanning of a human tissue or organ, such as Technetium, F18, C11, Indium 111, etc. In such an embodiment, the differentiating complex 46 emits radioactive radiation that is received by the GiPiII 30 upon approximation to the differentiating complex 46 (illustrated in figures 6g-6i).

In yet a further embodiment of the invention, the core 1 or the nanoparticle has electromagnetic characteristics. In such an embodiment, they may comprise or attached to Radio Frequency Identification (RFID) material or Nuclear Quadrupole Resonance (NQR) material (Fig. 2E-2F). In such an embodiment, the intracorporeal detecting unit that is comprised inside the GiPiII 30 transmits a specific signal correlated with a specific RFID or NQR material incorporated or attached to the differentiating complex. In response, the differentiating complex transmits a signal that signifies the existence of a tumor. In such an embodiment, the electromagnetic differentiating complex 45 comprises at least one type of RFID or NQR material.

Alternatively or additionally, the immunological differentiating complex comprises a polarized substance instead of a core, which provides the immunological differentiating complex a magnet characteristic or alters it to be susceptible to magnetic field.

Optionally, the differentiating complex comprises several types of tumor specific antibodies, wherein each type comprises a specific type of RFID or NQR material. In such an embodiment, receipt of a signal from a specific type of RFID or NQR allows both, identification of the existence of a tumor and localization of the tumor to specific organ in the subject's body according to the specificity of the antibody and the frequency of the transmission obtained.

Optionally, the differentiating complex is a metabolic differentiating complex 22 that comprises a labeling element. The term "labeling element" as used herein also includes a tracer and/or a marker. The labeling element may be any molecular labeling known in the art that is suitable for the screening system of the invention. Figures 2B and 2C respectively, illustrate embodiments of a metabolic differentiating complex 22 that comprises a core 1 covered by or attached to at least one type of metabolite 24 that is capable of entering into or attaching to a live cell as a matter of natural biological cell activity, such as Choline, Uridine, Glucose, folic acid and the like. In such an embodiment, the metabolic differentiating complex being administered to the subject may comprise one type of metabolite or a mixture of several types of metabolites.

The detection of a tumor by the metabolic differentiating complex 22 is enabled due to three major differences between tumorigenic tissue and normal healthy tissue: tumorigenic tissue is more prone to incorporate metabolic molecules compared to adjacent healthy tissue; the metabolism of tumorigenic tissue is higher than the metabolism of normal adjacent healthy tissue; and the blood flow to the tumorigenic tissue is higher than the blood flow to normal healthy tissue due to abnormal expansion of blood vessels in the tumor and abnormal leaky characteristic nature of these vessels. Thus, the concentration of the metabolic differentiating complex in the tumor is much higher compared to its concentration in a normal healthy tissue.

Additionally or alternatively, the metabolic differentiating complex may comprise a polarized substance (not shown) instead of a core. Optionally, the metabolic differentiating complex by itself is being polarized and as such it becomes susceptible to magnetic field.

In a specific embodiment of the invention, the metabolic differentiating complex comprises the tracer fluorine-18 fluorodeoxyglucose (F-18 FDG), a glucose analog that is taken up by glucose-using cells and is currently used for diagnosis and monitoring treatment of cancers as part of a PET scanning. The present invention provides a novel use of FDG as a component of the metabolic differentiating complex.

When the differentiating complex is administered to the subject intravenously by injection it is prepared for injection by immersing the complex in any proper solution made for injection that is known in the art such as water for injection.

When the differentiating complex is administered to a subject intracavitary, i.e. by oral or rectal route, preferable it is prepared in a form of a pill, syrup, gel capsules, drops, suppository, melting powder or any other form of medicament know in the art for intracavitary application. In such an embodiment, the differentiating complex may comprise at least one protective layer or protective coat such as enteric coating adapted to allow the differentiating complex to arrive to a target area in a functional form. Enteric coating ensures such a safe passage of the differentiating complex through the Gl tract until it passes the acidic surrounding of the stomach and reaches a target area, so as to avoid its destruction by the digesting activity of the Gl tract. The term "target area" as used herein includes without limitation the Gastro Intestinal tract and its ancillary organs as defined above and the prostate. Although the prostate is not a part of the Gl tract and it is not considered as its ancillary, the proximity of the prostate to the Gl tract allows the tumor screening system of the invention to screen tumors in the prostate as well.

Alternatively, the differentiating complex may comprise a mixture of coated and non coated complexes allowing the detection of all parts of the Gl tract. Alternatively, it may comprise multiple layers, wherein each layer is adapted to be exposed at different stages of the passage through the Gl tract.

Alternatively the differentiating complex is not coated but it is administered to the subject together with or following administration to the subject of a medicament adapted to modify temporary, the acidic environment of the stomach to a basic environment.

Figure 3 schematically illustrates three possible intrinsic properties of a differentiating complex according to preferred embodiments of the invention.

Figure 3A illustrates a magnetic differentiating complex 44. Figure 3B illustrates an electromagnetic differentiating complex 45, and Figure 3C illustrates a radioactive differentiating complex 46.

The differentiating complex may be in a size of a nano particle, a micro particle and any other size that is functionally suitable for the screening system of the invention. The size of the differentiating complex is determined, among other considerations, by the route of administering the differentiating complex to the subject i.e. intracavitary or intravenously.

In accordance with the present invention, after the differentiating complex is administered to a subject and spread in the subject's body, the screening of a tumor or tumors is performed by an intracorporeal detecting unit adapted for detecting in vivo at least one physical signal functionally associated with the differentiating complex. In a preferred embodiment of the invention, at least the intracorporeal detecting unit and the intracorporeal transmitting unit are arranged in housing in a form of a pill or a suppository that is adapted to be introduced to a subject intracavitary. The pill or the suppository is designated hereinafter: "Gastro Intestinal Pill" or "GiPiII". The GiPiII may comprise additional units of the screening system of the invention as described in details with reference to figure 4.

Reference is now made to Figures 4 and 5, which schematically illustrate optional structures of a "GiPiII" 30A₁ 3OB and 3OC, and an extracorporeal receiving device (ERD) 40 respectively, in accordance with preferred embodiments of the invention. Figure 4A illustrates basic structure of a passive GiPiII 3OA adapted to detect either a magnetic or a radioactive differentiating means according to preferred embodiments of the invention. The Passive GiPiII 3OA comprises a housing 6 in a form of a pill or a suppository that is introduced into the Gl tract intracavitary and it travels along the Gl tract until it is expelled from the body by defecation. In a preferred embodiment the average dimensions of the GiPiII are in the range of up to 30 mm length and up to 15 mm diameter, more preferably the dimensions are in the range up to 21 mm length and up to 8 mm diameter.

The housing 6 of GiPiII 30 may further comprise a micro control unit (MCU) and optionally, an activator, or both. The term "MCU" as used herein also includes a "controller" and both terms may be used hereinafter as synonyms.

The housing may further comprise a speedometer or an accelerometer to allow identifying a location of a detected tumor.

The intracorporeal detecting unit comprised in the GiPiII 3OA comprises at least a sensor 9 adapted for measuring a value of at least one of: a magnetic field, an electromagnetic field, an electric field, or alteration in said fields, and a radioactive emission level, and producing a signal correlative with the measured value. The produced signal is either transmitted directly to the ERD 40 by said intracorporeal transmitting unit via a transmitter 11 and optionally an antenna 12, or it is delivered to MCU 10 prior to transmission to the ERD 40. In such an embodiment, the MCU 10 functionally receives the produced signal from the intracorporeal detecting unit (in this specific embodiment from the sensor 9) and activates the intracorporeal transmitting unit (in this specific embodiment from the transmitter 11 and the antenna 12) upon identifying a change in the measured value compared to a predefined value, to transmit a signal outside the body, to an extracorporeal receiver 17 that is incorporated in the ERD 40. The GiPiII 3OA illustrated in Fig. 4A is adapted to sense and transmit signals, but it is not capable of creating a magnetic field or emitting a radioactive radiation by itself. Thus, this embodiment of the GiPiII is referred to as a passive GiPiII. When the passive GiPiII 3OA passes near an aggregation of differentiating complex that comprise for example, a magnetic field, it leads to the creation of electric current inside the GiPiII that is translated to a signal and submitted outside the body to the ERD 40. In a further embodiment of the present invention, the MCU 10 is further adapted for activating said intracorporeal transmitting unit to transmit a periodic verification signal indicating that said intracorporeal detecting unit is active.

Alternatively or additionally the differentiating complex comprises a radioactive material and the sensor 9 is a micro Geiger counter. The radioactive radiation emitted by the differentiating complex is detected by the sensor 9 and translated to a signal that is submitted outside the body.

The GiPiII 3OA further comprise a power supply unit 13, preferably a battery. Alternatively, the GiPiII 3OA does not comprise an internal power supply unit and it receives the energy to function from an extracorporeal element, for example by radio frequency transmission (not shown). Alternatively, the GiPiII housing 6 is made of a conductive material that upon crossing a magnetic field inside the body an electrical current is created that allows a transmission of a signal indicating said detection to the ERD 40. Assuming that the magnetic field inside the body is created by a magnetic differentiating complex, the transmission of a signal is indicative to tumor existence.

In accordance with embodiments of the invention, the signal transmitted to the ERD 40 is an electromagnetic signal or an ultrasonic signal. Optionally, the electromagnetic signal (e.g. Radio Frequency (RF) signal) is transmitted outside the body by a Bluetooth technology. Alternatively, the GiPiII 3OA comprises only a sensor 9 and a transmitter

11 (not shown). In such an embodiment, when the sensor do not detect any signal from the differentiating complex the transmitter 11 transmit a specific signal that indicate that no signal from the differentiating complex was detected, and upon detection of a signal it transmits another signal indicating the detection of such a signal. Alternatively, when the sensor detect a signal from the differentiating complex the transmitter transmits a signal indicating the detection of a signal, and when the sensor do not detect any signal from the differentiating complex the transmitter transmits no signal.

Figure 4B that illustrates a basic structure of an active GiPiII 3OB that comprises intracorporeal detecting unit with an electromagnetic (EM) field source 7 adapted for creating either one of a magnetic, electromagnetic or electric field or combinations thereof. The magnetic field created can be a permanent magnet or an electromagnet. The electromagnetic field source 7 can be activated continuously or it can be activated after it is swollen by the subject, for example by an activator 8. Optionally, activator 8 is adapted for activating the detecting unit either upon administering of the housing 6 to a subject or before administering to said subject upon deliberate activation. Optionally, activator 8 is adapted to detect the presence of GiPiII 3OB in the subject's body and to activate the GiPiII 3OB upon such detection. Activator 8 may be comprised in all embodiments of the GiPiII described in the present invention. Alternatively, GiPiII 30 may be activated upon removal from the package that it is stored before using and if it is not being used and it is restored in the package, it is deactivated until it is used.

When the active GiPiII 3OB proximate a differentiating complex that comprises metallic components, the metallic components interfere the magnetic field created by the GiPiII. The interference in the magnetic field leads to the detection of said differentiating complex. The active GiPiII 3OB further comprise a sensor 9 adapted to detect alteration in a magnetic field, electric field or to detect radioactivity. Sensor 9 is controlled by a micro control unit (MCU) 10, which activates a transmitter 11 adapted to transmit a signal outside the body, preferably through an antenna 12, to an extracorporeal receiver 17 incorporated in ERD 40 and connected to a Power Supply unit 13.

Optionally the active GiPiII 3OB is adapted for detecting differentiating complex comprising RFID or NQR material. In such an embodiment the EM field source 7 is a transmitter that transmits specific signals to the RFID or NQR material, and the sensor 9 is a receiver adapted for receiving the signals transmitted from the RFID and/or NQR materials as a response to that transmission. The signal obtained from the sensor is further delivered either through the MCU 10 or directly to transmitter 11 that transmits a different signal indicating positive detection of the differentiating complex to the ERD 40. Additionally or alternatively when no signal id obtained from the RFID or NQR materials the sensor 9 is adapted to deliver a different signal to MCU 10 or directly to transmitter 11 indicating no detection of differentiating complex.

Fig. 4C illustrates additional embodiment of an active GiPiII 3OC adapted to detect a differentiating complex comprising an RFID material or a NQR material. In such an embodiment, the intracorporeal detecting unit comprised in the GiPiII 3OC comprises at least a transmitter and a receiver or a transceiver 28, said transmitter is adapted for transmitting at least one radio frequency signal to a radio frequency identification material and said receiver is adapted for receiving at least one radio frequency signal from said radio frequency identification material indicating the presence of said material in a subject's body. The transmitter in accordance with this embodiment is further adapted for transmitting a signal to the ERD 40 upon receiving a signal from said radio frequency identification material. In such embodiment, the transmitter or the transceiver transmit at least two different RF signals, one signal is transmitted inside the subject's body to identify RFID that is incorporated or attached to the differentiating complex, while the other is transmitted outside the body to ERD 40 to indicate a detection of RFID.

In a specific embodiment of the invention, the differentiating complex comprises different RFIDs or NQRs and the transceiver is adapted to transmit different RF transmissions, each correlated to a specific RFID or NQR. When the transceiver 28 receives a response from the RFID or NQR material, MCU 10 instructs the transceiver to send an RF transmission in another frequency than the one used to detect the RFID material to ERD 40 to indicate a detection of a differentiating means in the subject's body. Alternatively or additionally, if after a predefined period of time the transceiver receives no response from the RFIDs or

NQRs of the differentiating complex, the MCU 10 instructs the transceiver 28 to send an RF transmission in another frequency than the one used to detect the RFID or NQR material and the one used to indicate positive detection, to thereby indicate no detection of differentiating complex. The active GiPiII 3OC further comprise a power supply unit 13 and optionally an antenna 12 as described in details above. Reference is now made to Figure 5, which schematically illustrates a basic structure ERD 40 in accordance with preferred embodiment of the invention. The ERD 40 is arranged in a housing 14 in a form of a hand watch, a medallion or an attachable device capable of being attached to a subject's body, to a belt, to an article of clothing of said subject or to be inserted to a pocket during the performance of a tumor screening procedure. The time period of such procedure is at least the time required for the GiPiII 30 to pass through the gastrointestinal tract. The ERD 40 comprises an extracorporeal receiver 17, preferably an electromagnetic energy receiver, or ultrasonic energy receiver, and optionally connected to a receiving antenna 16. In a specific embodiment, the electromagnetic energy is RF energy. The ERD 40 further comprises MCU 18 optionally with a recording capability that is functionally adapted for storing the transmitted signal. Alternatively, the MCU 18 do not have a recording capabilities and it is functionally connected to a storage unit 60 adapted for storing the transmitted signal for further extraction of said signal for analysis. Additionally, the ERD 40 is functionally connected to an independent device allowing to display or to extract stored signals. In such an embodiment, the ERD 40 may further comprises a connector 19 adapted to enable a connection of the ERD 40 to an independent unit such as a computer, a screen or both and any other independent unit that functionally allows the analysis of the stored signals. For the purposes of the invention, the computer may be a PC, a laptop or a palm top computer that can connect to the connector 19 either by a wire or by wireless connection. In a specific embodiment, the ECD 40 is a hand watch with Bluetooth facilities and the receiver 17 receives the signals from the GiPiII by Bluetooth technology. Alternatively or additionally, the ERD 40 comprises a memory card (not shown). The memory card can be a disposable element inserted into the device for each screening anew or re-used. In such an embodiment, the data recorded in the memory card is decoded by a card reader or transmitted to a computer either by a cable or by a wireless technology. The housing 14 of the extracorporeal device further contains a power source, preferably a battery 15.

Figure 6 is a schematic illustration of a GiPiII 30 detecting a tumor while traveling in the Gl tract according to preferred embodiments of the invention. Figures 6a - 6c illustrate RFID or NQR based screening system. Fig. 6a illustrates differentiating complex comprising RFIDs or NQRs accumulated in a tumor located in the gastro intestinal tract following intravascular administration of the differentiating complex to a subject; Fig. 6b illustrates differentiating complex attached to the surface of a tumor located in the gastro intestinal tract following intracavitary administration of the differentiating complex to a subject; Fig. 6c illustrates a differentiating complex accumulated in a tumor located outside the gastro intestinal tract in one of the gastro intestinal ancillaries or in the prostate following intravascular administration of the differentiating complex to the subject. Figures 6d-6f illustrate a magnetic based screening system. Fig. 6d illustrates differentiating complex accumulated in a tumor located in the gastro intestinal tract; Fig. 6e illustrates differentiating complex attached to the surface of a tumor located in the gastro intestinal tract; Fig. 6f illustrates a differentiating complex accumulated in a tumor located outside the gastro intestinal tract. Figures 6g-6i illustrate a radioactive emission based screening system in which the differentiating complex is accumulated in a tumor located inside the gastro intestinal tract (Fig. 6g), attached to the surface of a tumor located in the gastro intestinal tract (Fig.δh), and accumulated in a tumor located outside the gastro intestinal tract (Fig. 6i).

The present invention further provides methods for screening a tumor in the Gl tract, its ancillaries and the prostate of a subject. In a preferred embodiment of the invention the method comprises the steps of: a. Differentiating in vivo a tumor from normal tissue by a differentiating complex; b. Detecting in vivo at least one physical signal functionally associated with said differentiating complex by an intracorporeal detecting unit; c. Transmitting at least one signal correlated with said physical signal to an extracorporeal receiving device by an intracorporeal transmitting unit; and d. Receiving and storing said transmitted signal by an extracorporeal receiving device.

Optionally, the method for tumor screening further comprise a step of identifying a signal that is different from a predefined noise signal by amplitude, frequency, form and combinations thereof, to thereby allow indicating the existence of a tumor by an analyzing unit.

The differentiating complex used is this method is preferably administered to a subject either intravenously or intracavitary, but it may also be administered to a subject by inhalation or subcutaneously. The differentiating complex comprises at least one of an immunological differentiating complex, a metabolic differentiating complex, a nanoparticle, a polarized substance, a radio frequency identification material, a nuclear quadrupole resonance material, a bioactive agent, and combinations thereof.

Optionally, the immunological differentiating complex comprises a core covered by or attached to at least one layer comprising at least one type of tumor specific antibodies and wherein the metabolic differentiating complex comprises a core covered by or attached to at least one type of a metabolite capable of entering into or attaching to a live cell. Additionally or alternatively, the differentiating complex further comprises at least one protective layer or protective coat adapted to allow it to arrive to a target area in a functional form. The tumor specific antibodies that are suitable for the screening method of the present invention are selected from the group consisting of: gastro intestinal tract tumor specific antibodies, gastro intestinal tract ancillary tumor specific antibodies, prostate specific antibodies, and a mixture thereof.

Upon approximation of the intracorporeal detecting unit to the differentiating complex, the differentiating complex either creates or modifies at least one of a detectable: magnetic field, electric field, electromagnetic field, and combinations thereof. Alternatively or additionally, the differentiating complex emits radioactive radiation that is detected by the intracorporeal detecting unit upon approximation to the differentiating complex. In accordance with the present invention, at least the intracorporeal detecting unit and the intracorporeal transmitting unit are arranged in housing 6 in a form of a pill or a suppository (hereinafter: "GiPiII") that is adapted to be introduced to a subject intracavitary. The housing may further comprise a micro control unit (MCU), an activator, or both. The activator is adapted for activating the detecting unit either upon administering of the housing to the subject or before administering to the subject upon deliberate activation. The housing may further comprise a speedometer or an accelerometer to allow identifying the location of a detected tumor.

In accordance with the tumor screening method of the invention, the intracorporeal detecting unit comprises at least a sensor that is adapted for measuring a value of at least one of: a magnetic field, an electromagnetic field, an electric field or alteration in said fields, and a radioactive emission level, and producing a signal correlative with the measured value. The produced signal is either transmitted directly to the extracorporeal receiving device by the intracorporeal transmitting unit or it is delivered to a MCU 10 prior to transmission. In such an embodiment, the MCU functionally receives the produced signal from the intracorporeal detecting unit and activates the intracorporeal transmitting unit upon identifying a change in the measured value compared to a predefined value. Optionally, the MCU is further adapted for activating the intracorporeal transmitting unit to transmit a periodic verification signal indicating that the intracorporeal detecting unit is active. In a specific embodiment, the intracorporeal detecting unit comprises at least a transmitter and a receiver or a transceiver. The transmitter or the transceiver is adapted for transmitting at least one radio frequency signal to RFID or NQR material and the receiver or the transceiver is adapted for receiving at least one radio frequency signal from the RFID or NQR material indicating the presence of said material in a subject's body. Optionally, the transmitter is further adapted for transmitting a signal to the ERD 40 upon receiving a signal from said RFID or NQR material. Alternatively, the transmission outside the body is carried by additional transmitter.

Optionally or alternatively, the intracorporeal detecting unit further comprises an electromagnetic (EM) field source adapted for creating either one of a magnetic, electromagnetic or electric field or combinations thereof. ERD 40 of the screening method is preferably arranged in housing in a form of a hand watch, a medallion, or an attachable device capable of being attached to a subject's body, to a belt, to an article of clothing of the subject or to be inserted to a pocket during a performance of a tumor screening procedure. Optionally, the extracorporeal receiving device is functionally connected to an independent device allowing to display or to extract stored signals.

While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.

Claims

1. A tumor screening system comprising: a. A differentiating complex adapted for differentiating in-vivo a tumor from normal tissue; b. An intracorporeal detecting unit adapted for detecting in-vivo at least one physical signal functionally associated with said differentiating complex; c. An intracorporeal transmitting unit adapted for transmitting at least one signal correlated with said physical signal to an extracorporeal receiving device; and d. An extracorporeal receiving device adapted for receiving and storing said transmitted signal.

2. A tumor screening system according to claim 1 , further comprising an analyzing unit adapted for identifying a signal that is different from a predefined noise signal by amplitude, frequency, form, and combinations thereof, to thereby allow indicating the existence of a tumor.

3. A tumor screening system according to claim 1 , wherein said differentiating complex is administered to a subject either intravenously or intracavitary, and wherein said differentiating complex comprises at least one of an immunological differentiating complex, a metabolic differentiating complex, a nanoparticle, a polarized substance, a radio frequency identification material, a nuclear quadrupole resonance material, a bioactive agent, and combinations thereof.

4. A tumor screening system according to claim 3, wherein said immunological differentiating complex comprises a core covered by or attached to at least one layer comprising at least one type of tumor specific antibodies and wherein said metabolic differentiating complex comprises a core covered by or attached to at least one type of a metabolite capable of entering into or attaching to a live cell.

5. A tumor screening system according to claim 1 , wherein said differentiating complex further comprise at least one protective layer or protective coat adapted to allow it to arrive to a target area in a functional form.

6. A tumor screening system according to claim 4, wherein said tumor specific antibodies are selected from the group consisting of: gastro intestinal tract tumor specific antibodies, gastro intestinal tract ancillary tumor specific antibodies, prostate specific antibodies, and a mixture thereof.

7. A tumor screening system according to claim 1 , wherein upon approximation of said intracorporeal detecting unit to said differentiating complex, the differentiating complex either creates or modifies at least one of a detectable: magnetic field, electric field, electromagnetic field, and combinations thereof.

8. A tumor screening system according to claim 1 , wherein said differentiating complex emits radioactive radiation that is detected by said intracorporeal detecting unit upon approximation to said differentiating complex.

9. A tumor screening system according to claim 1 , wherein at least said intracorporeal detecting unit and said intracorporeal transmitting unit are arranged in a housing in a form of a pill or a suppository that is adapted to be introduced to a subject intracavitary.

10. A tumor screening system according to claim 9, wherein said housing further comprises a micro control unit, an activator, or both, and wherein said activator is adapted for activating said intracorporeal detecting unit either upon administering of said housing to a subject or before administering to said subject upon deliberate activation.

11. A tumor screening system according to claim 9, wherein said housing further comprise a speedometer or an accelerometer to thereby allow identifying a location of a detected tumor.

12. A tumor screening system according to claim 1 , wherein said intracorporeal detecting unit comprises at least a sensor, said sensor is adapted for measuring a value of at least one of: a magnetic field, an electromagnetic field, an electric field or alteration in said fields, and a radioactive emission level, and producing a signal correlative with the measured value.

13. A tumor screening system according to claim 12, wherein said produced signal is either transmitted directly to the extracorporeal receiving device by said intracorporeal transmitting unit or it is delivered to a micro control unit prior to transmission.

14. A tumor screening system according to claim 13, wherein said micro control unit functionally receives the produced signal from said intracorporeal detecting unit and activates said intracorporeal transmitting unit upon identifying a change in said measured value compared to a predefined value;

15. A tumor screening system according to claim 13, wherein said micro control unit is further adapted for activating said intracorporeal transmitting unit to transmit a periodic verification signal indicating that said intracorporeal detecting unit is active.

16. A tumor screening system according to claim 1 , wherein said intracorporeal detecting unit comprises at least a transmitter and a receiver or a transceiver, and wherein said transmitter is adapted for transmitting at least one radio frequency signal to a radio frequency identification material or nuclear quadrupole resonance material and said receiver is adapted for receiving at least one radio frequency signal from said radio frequency identification material or nuclear quadrupole resonance material indicating the presence of said material in a subject's body.

17. A tumor screening system according to claim 16, wherein said transmitter is further adapted for transmitting a signal to said extracorporeal receiving device upon receiving a signal from said radio frequency identification material or nuclear quadrupole resonance material.

18. A tumor screening system according to claim 1 , wherein said intracorporeal detecting unit further comprises an electromagnetic field source adapted for creating either one of a magnetic, electromagnetic or electric field or combinations thereof.

19. A tumor screening system according to claim 1, wherein said extracorporeal receiving device is arranged in housing in a form of a hand watch, a medallion, or an attachable device capable of being attached to a subject's body, to a belt, to an article of clothing of said subject or to be inserted to a pocket during a performance of a tumor screening procedure.

20. A tumor screening system according to claim 1 , wherein said extracorporeal receiving device is functionally connected to an independent device allowing to display or to extract stored signals.

21. A method for tumor screening in a subject, said method comprising the steps of: a. Differentiating in vivo a tumor from normal tissue by a differentiating complex; b. Detecting in vivo at least one physical signal functionally associated with said differentiating complex by an intracorporeal detecting unit; c. Transmitting at least one signal correlated with said physical signal to an extracorporeal receiving device by an intracorporeal transmitting unit; and d. Receiving and storing said transmitted signal by an extracorporeal receiving device.

22. A method for tumor screening according to claim 21 , further comprising a step of identifying a signal that is different from a predefined noise signal by amplitude, frequency, form and combinations thereof, to thereby allow indicating the existence of a tumor by an analyzing unit.

23. A method for tumor screening according to claim 21 , wherein said differentiating complex is administered to a subject either intravenously or intracavitary, and wherein said differentiating complex comprises at least one of an immunological differentiating complex, a metabolic differentiating complex, a nanoparticle, a polarized substance, a radio frequency identification material, a nuclear quadrupole resonance material, a bioactive, and combinations thereof.

24. A method for tumor screening according to claim 23, wherein said immunological differentiating complex comprises a core covered by or attached to at least one layer comprising at least one type of tumor specific antibodies and wherein said metabolic differentiating complex comprises a core covered by or attached to at least one type of a metabolite capable of entering into or attaching to a live cell.

25. A method for tumor screening according to claim 21 , wherein said differentiating complex further comprise at least one protective layer or protective coat adapted to allow it to arrive to a target area in a functional form.

26. A method for tumor screening according to claim 24, wherein said tumor specific antibodies are selected from the group consisting of: gastro intestinal tract tumor specific antibodies, gastro intestinal tract ancillary tumor specific antibodies, prostate specific antibodies, and a mixture thereof.

27. A method for tumor screening according to claim 21 , wherein upon approximation of said intracorporeal detecting unit to said differentiating complex, the differentiating complex either creates or modifies at least one of a detectable: magnetic field, electric field, electromagnetic field, and combinations thereof.

28. A method for tumor screening according to claim 21 , wherein said differentiating complex emits radioactive radiation that is detected by said intracorporeal detecting unit upon approximation to said differentiating complex.

29. A method for tumor screening according to claim 21 , wherein at least said intracorporeal detecting unit and said intracorporeal transmitting unit are arranged in a housing in a form of a pill or a suppository that is adapted to be introduced to a subject intracavitary.

30. A method for tumor screening according to claim 29, wherein said housing further comprises a micro control unit, an activator, or both, and wherein said activator is adapted for activating said detecting unit either upon administering of said housing to a subject or before administering to said subject upon deliberate activation.

31. A method for tumor screening according to claim 29, wherein said housing further comprise a speedometer or an accelerometer to thereby allow identifying a location of a detected tumor.

32. A method for tumor screening according to claim 21 , wherein said intracorporeal detecting unit comprises at least a sensor, said sensor is adapted for measuring a value of at least one of: a magnetic field, an electromagnetic field, an electric field or alteration in said fields, and a radioactive emission level, and producing a signal correlative with the measured value.

33. A method for tumor screening according to claim 32, wherein said produced signal is either transmitted directly to the extracorporeal receiving device by said intracorporeal transmitting unit or it is delivered to a micro control unit prior to transmission.

34. A method for tumor screening according to claim 33, wherein said micro control unit functionally receives the produced signal from said intracorporeal detecting unit and activates said intracorporeal transmitting unit upon identifying a change in said measured value compared to a predefined value;

35. A method for tumor screening according to claim 33, wherein said micro control unit is further adapted for activating said intracorporeal transmitting unit to transmit a periodic verification signal indicating that said intracorporeal detecting unit is active.

36. A method for tumor screening according to claim 21 , wherein said intracorporeal detecting unit comprises at least a transmitter and a receiver or a transceiver, and wherein said transmitter is adapted for transmitting at least one radio frequency signal to a radio frequency identification material or nuclear quadrupole resonance material and said receiver is adapted for receiving at least one radio frequency signal from said radio frequency identification material or nuclear quadrupole resonance material indicating the presence of said material in a subject's body.

37. A method for tumor screening according to claim 36, wherein said transmitter is further adapted for transmitting a signal to said extracorporeal receiving device upon receiving a signal from said radio frequency identification material or nuclear quadrupole resonance material.

38. A method for tumor screening according to claim 21 , wherein said intracorporeal detecting unit further comprises an electromagnetic field source adapted for creating either one of a magnetic, electromagnetic or electric field or combinations thereof.

39. A method for tumor screening according to claim 21 , wherein said extracorporeal receiving device is arranged in housing in a form of a hand watch, a medallion, or an attachable device capable of being attached to a subject's body, to a belt, to an article of clothing of said subject or to be inserted to a pocket during a performance of a tumor screening procedure.

40. A tumor screening system according to claim 21 , wherein said extracorporeal receiving device is functionally connected to an independent device allowing to display or to extract stored signals.