Trial Set for Ingested Colon Cancer Detection Capsule

(Marco Verch, Flickr)

11 May 2022. A clinical trial is set to begin assessing an electronic capsule designed to detect and transmit images from the gut to detect early cancer-causing polyps. The study is conducted by the Mayo Clinic in Rochester, Minnesota, and sponsored by Check-Cap Ltd., developer of the system, in Isfiya, Israel.

Check-Cap cites data estimating 1.9 million worldwide cases of colorectal cancer and 935,000 deaths each year, with 150,000 of those cases and 53,000 deaths in the U.S. At the same time, says the company, screening rates for colorectal cancer are low, since colonoscopies, the procedure to screen for the disease, requires extensive preparations to empty the colon, sedation of many patients, and an invasive endoscope. As a result, benign polyps in the colon in many asymptomatic individuals are going undetected, yet could be removed if identified before becoming tumors.

The Check-Cap system, called C-Scan, uses a capsule, small enough to be swallowed, containing a tiny X-ray emitting device and an image contrast agent.  The image contrast agent mixes with colon tissue, which gives off photons or light particles, read by X-ray detectors in the capsule. The close proximity of the capsule to the colon wall allows for low X-ray doses. At the same time, photons given off from the colon interact with electrons in the tissue, changing their direction and energy in measurable ways, a process called Compton scattering.

The capsule captures both sets of photons, and transmits the data to three collection units worn on the torso, where they’re relayed to a workstation. The company’s algorithms and software then process the data and prepare 3-D images of the colon interior surface for physicians, highlighting suspicious regions. Check-Cap says the C-Scan system is not intended to replace colonoscopies, but serves as a preliminary screening step. A positive C-Scan response, says the company, should be followed by a colonoscopy.

Two-part clinical trial

“Detecting precancerous polyps is needed to effectively prevent colorectal cancer,” says Check-Cap CEO Alex Ovadia in a company statement. Ovadia adds, “We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting.”

In an early-stage clinical study, reported by Science & Enterprise in Dec. 2019, 45 participants swallowed the C-Scan capsule, then had a colonoscopy to compare results. None of the participants completing the study reported any more than mild adverse effects, and later published results of the trial show the system with a true-positive sensitivity of 78 percent and true-negative specificity of 90 percent.

The new clinical trial is enrolling 952 healthy participants, age 50 to 75, at up to 15 sites in the U.S. In the first part of the study, some 200 participants will test the C-Scan system to help calibrate the device and analytics for average risk of colorectal cancer. In the second part of the trial, remaining participants will use the C-Scan system and receive a colonoscopy to detect precancerous polyps, with a sample size large enough to generate statistically reliable data for FDA’s decision-making needs.

The company expects to complete the calibration part of the trial, and begin the main data-gathering portion, in the fourth quarter of 2022.

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