Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colonic Polyps
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Feasibility and Sensitivity of OFDI Imaging in the Colon
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this research is to conduct a pilot clinical study to image colonic polyps with the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to identify the extent of invasion (if present), differentiate between hyperplastic polyps and adenomas, and identify serrated polyps.
Detailed Description
The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and the base/stalk if pedunculated. The investigators anticipate that on average the investigators will utilize 4 helical scans per polyp. Each of the scans will take less than 30 seconds.
Investigators
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing a screening colonoscopy
- •Patients must be over the age of 18
- •Patient must be able to give informed consent
Exclusion Criteria
- •Patients with hemostasis disorders
- •Patients taking any anti-coagulants such as Coumadin or Plavix,
Outcomes
Primary Outcomes
Feasibility and Sensitivity of OFDI Imaging in the Colon
Time Frame: During the OFDI imaging session which should take an average of 5 mintues
OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.