Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus (IVLCM)

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.

Study Overview

• Status: Recruiting
• Conditions: Barrett Esophagus
• Intervention / Treatment: Device: IVLCM tethered capsule

Detailed Description

In Vivo Laser Capture Microdissection (IVLCM). The IVLCM tethered capsule is identical to those used in current approved OCT TCE studies.The capsule is swallowed by the patient and then, in real time, a region for tissue capture, is identified on the images. When a targeted site is identified, a capture laser (1450 nm, 0.8 W, 1 second exposure; within the range of the previously approved OCT-TCE tissue marking study) irradiates this area in the patient, heating the water in the tissue and transforming it to steam. The accumulated water steam overcomes the tissue matrix's adhesion force, ejecting a small amount of tissue and integrating it with the capsule's external shell. This process may then be repeated to collect multiple samples. After the device is pulled out from the patient, the captured tissues can be extracted for genomic analysis. Ex vivo animal tissue studies have shown that capture laser does not damage DNA/RNA; high quality whole genome information can be obtained.

In this IVLCM study, the investigators are using a 1450 nm laser to capture tissue that was previously approved to make cautery "marks" in the esophagus. The IVLCM capture laser's specifications are the same as those of the marking laser and the power will be within the IRB approved power range (0.82 W 1s). Prior to testing laser marking in humans, the investigators first demonstrated the safety of laser marking in animals in vivo. Histological assessment showed that the cautery marks did not penetrate through the submucosa and the vast majority of the effects were limited to the epithelium, lamina propria, and muscularis mucosa layers. The extent of thermal damage was comparable to conventional biopsies in standard of care endoscopic biopsy procedures. After this animal study, the investigators conducted a pilot study in humans in which over 30 marks were made in 22 enrolled subjects without any adverse events or safety concerns. In addition to these balloon studies, the investigators are currently conducting a TCE marking study. So far, the investigators have imaged and marked 13 subjects through a capsule without any adverse effects or safety concerns.

Thirty (N=30) subjects will be enrolled in this study.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Gao, RN; Phone Number: 617-643-6092; Email: Tearneylabtrials@partners.org
• Study Contact Backup: Name: Anita Chung, RN; Phone Number: 617-724-4515; Email: TEARNEYLABTRIALS@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Anna Gao, RN; Phone Number: 617-643-6092; Email: Tearneylabtrials@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing an EGD with biopsy.
• Patients must be over the age of 18.
• Patients must be able to give informed consent.

Exclusion Criteria:

• Pregnant women.
• Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.
• Patients with a history of hemostasis disorders.
• Patients with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVLCM tethered capsule for biopsies; IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.	Device: IVLCM tethered capsule; Obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects from which we will be able to collect biopsy samples using IVLCM technique	We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique	5 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institutes of Health (NIH); National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Gary Tearney, MD., PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: OCT; Biopsy; Endoscopy; EGD; Barrett's Esophagus; Tethered Capulse Endomicroscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 2017-P001752; 5R01EB022077-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No