Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
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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 |
- 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 |
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| Contact: Guillermo Tearney, MD PhD | 617-724-2979 | gtearney@partners.org |
| Contact: Mireille Rosenberg, PhD | 617-726-9145 | mrosenberg@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Norman Nishioka, MD 617-726-4422 nnishioka@partners.org | |
| 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 May 23, 2013