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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439633
First Posted: September 23, 2011
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
  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 OFDI marking Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Guillermo Tearney, 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 ]
    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.


Enrollment: 22
Study Start Date: October 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGH OFDI marking and imaging
OFDI imaging
Device: MGH OFDI marking
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439633


Locations
United States, Massachusetts
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2011
First Posted: September 23, 2011
Last Update Posted: April 18, 2016
Last Verified: April 2016

Keywords provided by Guillermo Tearney, 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