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Study demonstrates feasibility, safety of X-ray imaging capsule for CRC screening
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HONOLULU — A novel prep-less X-ray imaging capsule for colon cancer screening safely and effectively detected polyps, according to preliminary data from an ongoing multicenter study presented at ACG 2015.
“The premise behind this prep-less X-ray capsule is that, even though colonoscopy is the gold standard for colon cancer screening and there are some other tests out there, we’re still not capturing all eligible patients that would benefit from colon cancer screening,” Seth A. Gross, MD, FACG, from New York University Langone Medical Center, told Healio Gastroenterology. “One of the potential barriers for someone to get a colonoscopy may be issues with bowel preparation, [which] this overcomes.”
The device, which is being developed by Check-Cap, is an “ingestible capsule that utilizes proprietary, ultra–low-energy X–ray-based technology to safely generate high-resolution, 3-dimensional imagery of the interior of the colon,” according to a press release. “Without requiring traditional bowel cleansing or diet and activity modifications, Check-Cap’s system is designed to increase patient acceptance and adherence to colorectal cancer screening recommendations. The Check-Cap system is currently not cleared for marketing in any jurisdiction,” however, the company plans to submit data from this study for CE Mark in the first quarter of 2016 and plans to initiate a U.S. pivotal trial in the second half of 2016.
Gross and his colleague, Nadir Arber, MD, from Tel Aviv Sourasky Medical Center in Israel, evaluated 49 volunteers (aged 37-66 years) who swallowed the capsules, which were tracked through the entire passage through the GI tract, during which time the system scanned the colon and transmitted data to an external recorder unit attached to the participant’s lower back. These data were then used to reconstruct 3D colon segments.
All capsules were successfully swallowed and excreted with no related adverse events reported, and the mean transit time was 68 ± 31 hours. Average total radiation exposure was “ultra-low” at 0.03 ± 0.007 mSv, which is “approximately equivalent to a single chest X-ray,” according to the press release. Quantitative ultra–low-dose X-ray 3D imaging of the colon was achieved, and multiple reconstructions of colon segments with polyps were successfully generated. A larger multicenter trial will be required to validate this colon screening modality.
"Early screening for colorectal cancer is the best way to prevent disease progression and mortality,” Gross said in the press release. “These data suggest that a noninvasive, preparation-free alternative may be a feasible alternative modality to help address this significant unmet medical need.” – by Adam Leitenberger
Reference:
Gross SA, et al. Abstract P1571. Presented at: ACG 2015; Oct. 19-21, 2015; Honolulu, HI.
Disclosures: Gross reports he is a consultant for Check-Cap.