Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

MGH OFDI Imaging

Guillermo Tearney, MD PhD

Norman Nishioka, MD

The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.

This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.

Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (\~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.

Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.

Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation

Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.

Massachusetts General Hospital

Professor of Pathology

OFDI imaging

MGH OFDI Imaging: Imaging of Esophagus with OFDI system

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Gary Tearney, PI

Imaging sessions with successful OFDI imaging

Imaging session w/ OFDI & corresponding pathology

Total number of imaging sessions conducted

Feasibility

A total of 17 Participants took place in this study.

Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation	NCT01439594	Barrett's Esoph...	MGH OFDI Imagin...	18 Years -	Massachusetts General Hospital
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation	NCT01439594	Barrett's Esoph...	MGH OFDI Imagin...	18 Years -	Massachusetts General Hospital

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