Optical Frequency Domain Imaging for Assessing Colonic Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01439087
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : April 15, 2016
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Device: MGH Optical Frequency Domain Imaging (OFDI) System Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps
Study Start Date : July 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: OFDI imaging
OFDI imaging
Device: MGH Optical Frequency Domain Imaging (OFDI) System
Imaging of Colonic Polyps with OFDI system

Primary Outcome Measures :
  1. Sensitivity and specificity of OFDI imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 mintues ]
    OFDI Images will be analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Accepts Healthy Volunteers:   No

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01439087

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital Identifier: NCT01439087     History of Changes
Other Study ID Numbers: 2009-P-000946
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Colonic Polyps

Additional relevant MeSH terms:
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps