Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01439594
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 65
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: MGH OFDI Imaging	N/A

Detailed Description

This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.

Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.

Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 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 the Tissue Response to Radiofrequency Ablation
• Actual Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGH OFDI Imaging OFDI imaging	Device: MGH OFDI Imaging; Imaging of Esophagus with OFDI system

Outcome Measures

Primary Outcome Measures

1. Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions [During the OFDI imaging session (about 5 minutes)]

   Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with a diagnosis of Barrett's esophagus

• Patients undergoing an Esophagogastroduodenoscopy (EGD)

• Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation

• Patients must be over the age of 18

• Patient must be able to give informed consent

• Women with child bearing potential must have a negative pregnancy test prior to procedure

Exclusion Criteria:

• Patients on oral anticoagulation medications

• Patients with a history of hemostasis disorders

• Patients that are pregnant

• Patients with esophageal strictures

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
• Principal Investigator: Norman Nishioka, MD, 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: NCT01439594
• Other Study ID Numbers: 2008-P000793
• First Posted: Sep 23, 2011
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Barrett's Esophagus; Esophagus; OCT; Imaging; Radiofrequency Ablation; BARRX
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

Participant Flow

Arm/Group Title	MGH OFDI Imaging
Arm/Group Description	OFDI imaging MGH OFDI Imaging: Imaging of Esophagus with OFDI system
Period Title: Overall Study
STARTED	17
COMPLETED	17
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	MGH OFDI Imaging
Arm/Group Description	OFDI imaging MGH OFDI Imaging: Imaging of Esophagus with OFDI system
Overall Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 52.9%
>=65 years	8 47.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (10)
Sex: Female, Male (Count of Participants)
Female	1 5.9%
Male	16 94.1%
Region of Enrollment (participants) [Number]
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
Description	Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.
Time Frame	During the OFDI imaging session (about 5 minutes)

Outcome Measure Data

Analysis Population Description

A total of 17 Participants took place in this study.

Arm/Group Title	Feasibility
Arm/Group Description	Total number of imaging sessions conducted
Measure Participants	17
Measure Completed Imaging sessions	64
Imaging sessions with successful OFDI imaging	64
Imaging session w/ OFDI & corresponding pathology	29

Adverse Events

Arm/Group Title	MGH OFDI Imaging
Arm/Group Description	OFDI imaging MGH OFDI Imaging: Imaging of Esophagus with OFDI system
All Cause Mortality
	MGH OFDI Imaging
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	MGH OFDI Imaging
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	MGH OFDI Imaging
	Affected / at Risk (%)	# Events
Total	0/17 (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.