Ingestible X-Ray Capsule Could Address Issues in Preventive Screenings for Colonoscopies

Check-Cap Ltd.’s (Isfiya, Israel; www.check-cap.com) C-Scan system is the first and only preparation-free test to detect precancerous polyps and enable early intervention and cancer prevention. A large part of the screening age population avoids standard screening procedures such as colonoscopy. C-Scan system has the potential to offer a more patient-friendly option, enabling people to get the screening they need.

Once the ingestible capsule C-Scan Cap is swallowed, it travels naturally along the gastrointestinal tract while scanning the inner lining of the colon. C-Scan Cap actively communicates with the second element of the system, C-Scan Track, which records and stores the scanning data. When the screening procedure is over, C-Scan Cap will be excreted naturally, the patient is notified, and the scanning data can be analyzed by using the company’s proprietary software, C-Scan View.

The C-Scan’s technology is based on two physical phenomena related to the interaction of the X-ray photons emitted by the capsule with the contents of the colon and the tissue wall. The first is X-ray fluorescence: When X-ray photons interact with the ingested contrast agent that mixes with the colon content, secondary X-ray fluorescence photons are generated, some of which are back scattered and detected by the x-ray detectors in the capsule. The second phenomenon is Compton scattering: When emitted X-ray photons interact with electrons of atoms in the colon wall and lumen some of the photons scattered by this mechanism head back in the direction of the capsule with an energy correlated to their angle of scatter.

The number of detected X-ray fluorescence photons and Compton back-scattered photons is correlated to the distance between the capsule and the colon wall. As the distance between the capsule and the colon wall increases, presence of content induces higher rates of X-ray fluorescence photons. At the same time, the content attenuates Compton back-scattered photons, hence decreasing the corresponding detection rate. The close proximity of the capsule to the scanning target allows for the use of an ultra-low dose radiation, since a very low x-ray flux is required to obtain sufficient signal-to-noise ratio and good scanning quality.

In a multi-center, open label prospective study, the C-Scan System demonstrated high sensitivity and specificity for the detection of precancerous polyps when compared to FIT (fecal immunochemical test), a commonly used non-invasive colorectal cancer screening test. Colonoscopy was used as the reference method.

"Our prospective single-arm pilot study demonstrated positive safety results and high patient satisfaction with a new and unique preparation-free colon capsule system intended for detection of colorectal polyps and masses," said Elizabeth Rajan, M.D., principal investigator of the study, gastroenterologist and professor of medicine, Mayo Clinic, Rochester. "This study represents a step forward to a prepless approach for CRC screening that may overcome one of the most important deterrents to screening. A multicenter pivotal study is planned in the U.S. to further validate the performance of this technology."

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