Optical Frequency Domain Imaging for Assessing Colonic Polyps

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01439087
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps
• Actual Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Feasibility and Sensitivity of OFDI Imaging in the Colon [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Guillermo Tearney, MD PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01439087
• Other Study ID Numbers: 2009-P000946
• First Posted: Sep 22, 2011
• Last Update Posted: Dec 30, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital: Colonic Polyps; OCT; Imaging; Colon; Polyp
• Additional relevant MeSH terms: Polyps; Colonic Polyps

Study Results

Participant Flow

Arm/Group Title	OFDI Imaging
Arm/Group Description	OFDI imaging MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	OFDI Imaging
Arm/Group Description	OFDI imaging MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 100%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility and Sensitivity of OFDI Imaging in the Colon
Description	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.
Time Frame	During the OFDI imaging session which should take an average of 5 mintues

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility & Sensitivity of OFDI Imaging in the Colon
Arm/Group Description	Feasibility is measured by the number of enrolled subjects that met imaging eligibility criteria and were successfully imaged with the OFDI device. Sensitivity is measured by the number of enrolled subjects that met eligibility criteria, and had a polyp(s) successfully imaged and identified by the OFDI device.
Measure Participants	2
Feasibility	2 100%
Sensitivity	1 50%

Adverse Events

Arm/Group Title	OFDI Imaging
Arm/Group Description	OFDI imaging MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system
All Cause Mortality
	OFDI Imaging
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	OFDI Imaging
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	OFDI Imaging
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.