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

Barrett's Esophagus Clinical Trial

Official title:

Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439633
• Other study ID #: 2010-P-000553
• Secondary ID: 2R01CA103769-06A
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• MGH OFDI marking
Imaging of esophagus with OFDI system

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.	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.	day 1, during diagnostic procedure