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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Barrett's Esophagus

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility and specificity of OFDI marking and imaging

Outcome Description:

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.

Outcome Time Frame:

Images will be acquired during the OFDI imaging session which should take an average of 5 mintues

Safety Issue:

No

Principal Investigator

Guillermo Tearney, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

2010-P-000553

NCT ID:

NCT01439633

Start Date:

October 2010

Completion Date:

October 2015

Related Keywords:

  • Barrett's Esophagus
  • Barrett's Esophagus
  • Esophagus
  • OCT
  • Imaging
  • Barrett Esophagus

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617