Pilot Study for OCT Guided in Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients undergoing an EGD with biopsy.

• Patients must be over the age of 18.

• Patients must be able to give informed consent.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Anita Chung, RN
Tearneylabtrials@partners.org
617-643-6092
Backup
Elizabeth Biddle, RN
Tearneylabtrials@partners.org
617-724-4515
Time Frame
Start Date: 2017-12-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: IVLCM tethered capsule for biopsies
IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov