Clinical trial NCT01439633: Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
Official title: Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Esophagus
OCT
Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2011-09-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.
timeFrame: day 1, during diagnostic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Norman Nishioka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suter MJ, Gora MJ, Lauwers GY, Arnason T, Sauk J, Gallagher KA, Kava L, Tan KM, Soomro AR, Gallagher TP, Gardecki JA, Bouma BE, Rosenberg M, Nishioka NS, Tearney GJ. Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study. Gastrointest Endosc. 2014 Jun;79(6):886-96. doi: 10.1016/j.gie.2013.11.016. Epub 2014 Jan 23.