RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-12-06
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03830801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing an EGD with biopsy.
  2. * Patients must be over the age of 18.
  3. * Patients must be able to give informed consent.
  1. * Pregnant women.
  2. * Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
  3. * Patients with a history of hemostasis disorders.
  4. * Patients with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule.

Contacts and Locations

Study Contact

Anita Chung, RN
CONTACT
617-643-6092
Tearneylabtrials@partners.org
Elizabeth Biddle, RN
CONTACT
617-724-4515
Tearneylabtrials@partners.org

Principal Investigator

Gary Tearney, MD., PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Gary Tearney, MD., PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-12-06
Study Completion Date2026-12

Study Record Updates

Study Start Date2017-12-06
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Barrett's Esophagus
  • EGD
  • Endoscopy
  • Biopsy
  • Tethered Capsule Endomicroscopy
  • OCT

Additional Relevant MeSH Terms

  • Barrett Esophagus