Using AI to detect remaining lesions after colon cancer treatment
Accuracy of CAD Eye in the Detection of Colonic Remaining Lesions After Endoscopic Mucosal Resection: a Pilot Study
This study is testing whether an AI tool can help doctors find leftover lesions after colon cancer treatment to improve detection during follow-up procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Instituto Ecuatoriano de Enfermedades Digestivas Academic / other |
| Locations | 1 site (Guayaquil, Guayas) |
| Trial ID | NCT05542030 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the CAD-Eye™ system, an artificial intelligence tool, in identifying remaining lesions after endoscopic mucosal resection (EMR) for colorectal dysplasia and neoplasms. The research aims to improve diagnostic accuracy during colonoscopy by comparing outcomes between procedures performed with and without CAD-Eye™ assistance. Participants will undergo EMR followed by a follow-up colonoscopy to assess the presence of any remaining lesions. The study focuses on enhancing the detection of difficult-to-treat lesions that may be missed during standard procedures.
Who should consider this trial
Good fit: Ideal candidates are patients referred for colonoscopy and EMR due to lesions suspected of high-grade dysplasia or early invasive cancer.
Not a fit: Patients with clinical conditions that make EMR unviable or those with poor bowel preparation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate detection of residual lesions, potentially reducing the risk of colorectal cancer recurrence.
How similar studies have performed: Previous studies have shown promising results for CAD-Eye™ in polyp detection, but its application for detecting remaining lesions after EMR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred to our center with an indication of colonoscopy and EMR for the treatment of lesions suspicious of high-grade dysplasia and early invasive cancer. * Patients who authorize EMR and colonoscopy. * Signed informed consent Exclusion Criteria: * Any clinical condition which makes EMR inviable. * Poor bowel preparation score defined as the total Boston bowel preparation score (BBPS) \<6 and the right-segment score \<2 * Patients with more than one previous EMR * Lost on a three-month follow-up after EMR * Pregnancy or nursing
Where this trial is running
Guayaquil, Guayas
- Carlos Robles-Medranda — Guayaquil, Guayas, Ecuador (Recruiting)
Study contacts
- Principal investigator: Carlos Robles-Medranda, MD FASGE — Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
- Study coordinator: Carlos Robles-Medranda, MD FASGE
- Email: carlosoakm@yahoo.es
- Phone: +59342109180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.