Optical Frequency Domain Imaging for Assessing Colonic Polyps

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.

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Key information

Conditions

Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

MGH Optical Frequency Domain Imaging (OFDI) System

Device

Imaging of Colonic Polyps with OFDI system

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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Sep 22, 2011
Registry last updated: Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed