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Spots Global Cancer Trial Database for Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

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Trial Identification

Brief Title: Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

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

Study ID: NCT01439594

Interventions

MGH OFDI Imaging

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Massachusetts General Hospital, Boston, Massachusetts, United States

Contact Details

Name: Guillermo Tearney, MD PhD

Affiliation: Massachusetts General Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Norman Nishioka, MD

Affiliation: Massachusetts General Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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