Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01439633
• Collaborator: National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
• Enrollment: 22
• Location: 1
• Arm: 1
• Duration (Months): 43
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The specific aim of this study is to determine the feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.

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

Detailed Description

Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and cautery marking for targeted biopsy, the patients will undergo a standard of care clinical Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study requires the use of a balloon catheter which is a commonly used technique and is accepted in clinical practice for dilation of esophageal and colonic strictures and for photodynamic therapy.

Once in position, the OFDI tissue marking laser will be activated by the physician. The physician will control the marking and make two marks of a duration of 2 seconds each. The 2 seconds time period will limit the tissue effects to only the superficial layers of the esophageal mucosa.

It is expected that the total experimental time including insertion and inflation of the OFDI balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add approximately 15 minutes to the total length of the EGD.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGH OFDI marking and imaging OFDI imaging	Device: MGH OFDI marking; Imaging of esophagus with OFDI system

Outcome Measures

Primary Outcome Measures

1. Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. [day 1, during diagnostic procedure]

   Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length

• 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 anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure

• 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
• National Institutes of Health (NIH)
• National Cancer Institute (NCI)

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: NCT01439633
• Other Study ID Numbers: 2010-P-000553; 2R01CA103769-06A1
• First Posted: Sep 23, 2011
• Last Update Posted: Apr 10, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital: Barrett's Esophagus; Esophagus; OCT; Imaging
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

Participant Flow

Arm/Group Title	MGH OFDI Marking and Imaging
Arm/Group Description	OFDI imaging MGH OFDI marking: Imaging of esophagus with OFDI system
Period Title: Overall Study
STARTED	22
COMPLETED	22
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	MGH OFDI Marking and Imaging
Arm/Group Description	OFDI imaging MGH OFDI marking: Imaging of esophagus with OFDI system
Overall Participants	22
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 36.4%
>=65 years	14 63.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (11.84)
Sex: Female, Male (Count of Participants)
Female	5 22.7%
Male	17 77.3%
Region of Enrollment (participants) [Number]
United States	22 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.
Description	Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.
Time Frame	day 1, during diagnostic procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGH OFDI Marking and Imaging
Arm/Group Description	OFDI imaging MGH OFDI marking: Imaging of esophagus with OFDI system
Measure Participants	22
Count of Participants [Participants]	22 100%

Adverse Events

Arm/Group Title	MGH OFDI Marking and Imaging
Arm/Group Description	OFDI imaging MGH OFDI marking: Imaging of esophagus with OFDI system
All Cause Mortality
	MGH OFDI Marking and Imaging
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Serious Adverse Events
	MGH OFDI Marking and Imaging
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Other (Not Including Serious) Adverse Events
	MGH OFDI Marking and Imaging
	Affected / at Risk (%)	# Events
Total	0/22 (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.