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

Mass General Brigham

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Device: MGH OFDI marking

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01439633

2R01CA103769-06A1 (U.S. NIH Grant/Contract)

2010-P-000553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

MGH OFDI marking and imaging

Experimental group

Description:

OFDI imaging

Treatment:

Device: MGH OFDI marking