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

This study is currently recruiting participants.
Verified September 2011 by Massachusetts General Hospital
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01439633
First received: September 20, 2011
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Barrett's Esophagus
Device: MGH Optical Frequency Domain Imaging (OFDI) system
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Feasibility and specificity of OFDI marking and imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 mintues ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFDI imaging
OFDI imaging
Device: MGH Optical Frequency Domain Imaging (OFDI) system
Imaging of esophagus with OFDI system

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439633

Contacts
Contact: Guillermo Tearney, MD PhD 617-724-2979 gtearney@partners.org
Contact: Mireille Rosenberg, PhD 617-726-9145 mrosenberg@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Norman Nishioka, MD    617-726-4422    nnishioka@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital
Principal Investigator: Norman Nishioka, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01439633     History of Changes
Other Study ID Numbers: 2010-P-000553, 2R01CA103769-06A1
Study First Received: September 20, 2011
Last Updated: September 21, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Barrett's Esophagus
Esophagus
OCT
Imaging

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014