Feature

Q&A: Study to evaluate usability of a prep-free colon cancer screening tool

Seth Gross, MD
Seth A. Gross

The emergence of noninvasive colorectal cancer screening options such as fecal immunochemical tests, CT colonography and digestible X-ray capsules have helped boost colon cancer screening rates in some individuals.

Colon cancer is the third most common cancer in the United States, according to the American Cancer Society, and while preventable, around half of the recommended screening population avoids tests such as colonoscopy due to the invasiveness and bowel preparation associated with the procedure.

Healio Gastroenterology and Liver Disease spoke with Seth A. Gross, MD, FACG, director of Clinical Care and Quality in the Division of Gastroenterology at NYU Langone Health, about a study he and colleagues are conducting that will evaluate the C-Scan system’s (Check-Cap), a novel X-ray imaging capsule that does not require bowel cleansing, ability to increase screening adherence.

Healio: Why is it concerning that approximately half of screening-eligible individuals avoid procedures such as colonoscopy?

Gross: Evidence strongly suggests that screening can reduce the incidence of colorectal cancer (CRC) and its associated economic burden and mortality. CRC typically begins as precancerous polyps that are often asymptomatic and can be present in the colon for up to 10 years before developing into invasive cancer. As a result, screening for precancerous polyps with structural screening methods is the most direct method for potentially preventing CRC. Colonoscopy is considered the gold standard of CRC screening methods, yet, in the U.S. about half of the targeted screening population avoids recommended screening, often due to the required laxative preparation, fasting requirements, required sedation, concerns over pain and insertion of the endoscope. The concern surrounds the fact that half of the population that is considered to be of sufficient risk for CRC to warrant regular screening avoids it despite the high preventability of this cancer.

Healio: What is the C-Scan system and how does the development of this product aim to change and reduce the number of people who fail to get screened?

Gross: The C-Scan system is a preparation-free ingestible scanning capsule for the prevention of CRC through the detection of precancerous polyps. The system is comprised of an X-ray scanning capsule that communicates with a tracking and recording unit as well as proprietary software to generate 3D maps of the inner lining of the colon for the detection of precancerous polyps and other abnormalities. This screening modality is non-invasive, requires no preparation or sedation and involves no pain or discomfort as it allows the patient to continue their daily routine with no interruption. As a patient-friendly screening method, the system aims to increase screening adherence for those unwilling or unable to use colonoscopy.

Healio: What is the objective of the trial?

Gross: The objectives of the trial are to evaluate the safety of the system, evaluate subject compliance and satisfaction and to collect data to improve the products polyp detection algorithm.

Healio: What do the investigators hope to identify after reviewing the results?

Gross: We are aiming to evaluate the usability of the system and its ability to provide structural information on colonic polypoid lesions and masses.

Healio: Are there any concerns with missed adenomas in terms of the capsule relying on a person’s motility to move the camera through the gastrointestinal system?

Gross: The capsule is propelled through the gastrointestinal tract by natural motility and the patient is notified when the capsule is excreted naturally. Relying on the patient’s natural motility means that the patient can continue their daily routines with no interruption and therefore offers the potential to increase screening compliance and the potential to increase the likelihood of detecting precancerous polyps and other abnormalities. Further, the data collected as a part of this trial will be used to improve the products algorithm and further maximize the sensitivity and specificity of the system’s ability to detect precancerous polyps.

Healio: When is the trial expected to begin?

Gross: Now that the pilot study has received approval from the Institutional Review Board, we expect to begin enrolling patients soon. We estimate that the study will be completed within the second half of this year.

Disclosure: Gross reports no relevant financial disclosures.

Seth Gross, MD
Seth A. Gross

The emergence of noninvasive colorectal cancer screening options such as fecal immunochemical tests, CT colonography and digestible X-ray capsules have helped boost colon cancer screening rates in some individuals.

Colon cancer is the third most common cancer in the United States, according to the American Cancer Society, and while preventable, around half of the recommended screening population avoids tests such as colonoscopy due to the invasiveness and bowel preparation associated with the procedure.

Healio Gastroenterology and Liver Disease spoke with Seth A. Gross, MD, FACG, director of Clinical Care and Quality in the Division of Gastroenterology at NYU Langone Health, about a study he and colleagues are conducting that will evaluate the C-Scan system’s (Check-Cap), a novel X-ray imaging capsule that does not require bowel cleansing, ability to increase screening adherence.

Healio: Why is it concerning that approximately half of screening-eligible individuals avoid procedures such as colonoscopy?

Gross: Evidence strongly suggests that screening can reduce the incidence of colorectal cancer (CRC) and its associated economic burden and mortality. CRC typically begins as precancerous polyps that are often asymptomatic and can be present in the colon for up to 10 years before developing into invasive cancer. As a result, screening for precancerous polyps with structural screening methods is the most direct method for potentially preventing CRC. Colonoscopy is considered the gold standard of CRC screening methods, yet, in the U.S. about half of the targeted screening population avoids recommended screening, often due to the required laxative preparation, fasting requirements, required sedation, concerns over pain and insertion of the endoscope. The concern surrounds the fact that half of the population that is considered to be of sufficient risk for CRC to warrant regular screening avoids it despite the high preventability of this cancer.

Healio: What is the C-Scan system and how does the development of this product aim to change and reduce the number of people who fail to get screened?

Gross: The C-Scan system is a preparation-free ingestible scanning capsule for the prevention of CRC through the detection of precancerous polyps. The system is comprised of an X-ray scanning capsule that communicates with a tracking and recording unit as well as proprietary software to generate 3D maps of the inner lining of the colon for the detection of precancerous polyps and other abnormalities. This screening modality is non-invasive, requires no preparation or sedation and involves no pain or discomfort as it allows the patient to continue their daily routine with no interruption. As a patient-friendly screening method, the system aims to increase screening adherence for those unwilling or unable to use colonoscopy.

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Healio: What is the objective of the trial?

Gross: The objectives of the trial are to evaluate the safety of the system, evaluate subject compliance and satisfaction and to collect data to improve the products polyp detection algorithm.

Healio: What do the investigators hope to identify after reviewing the results?

Gross: We are aiming to evaluate the usability of the system and its ability to provide structural information on colonic polypoid lesions and masses.

Healio: Are there any concerns with missed adenomas in terms of the capsule relying on a person’s motility to move the camera through the gastrointestinal system?

Gross: The capsule is propelled through the gastrointestinal tract by natural motility and the patient is notified when the capsule is excreted naturally. Relying on the patient’s natural motility means that the patient can continue their daily routines with no interruption and therefore offers the potential to increase screening compliance and the potential to increase the likelihood of detecting precancerous polyps and other abnormalities. Further, the data collected as a part of this trial will be used to improve the products algorithm and further maximize the sensitivity and specificity of the system’s ability to detect precancerous polyps.

Healio: When is the trial expected to begin?

Gross: Now that the pilot study has received approval from the Institutional Review Board, we expect to begin enrolling patients soon. We estimate that the study will be completed within the second half of this year.

Disclosure: Gross reports no relevant financial disclosures.