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

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ClinicalTrials.gov Identifier: NCT03830801
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Device: IVLCM tethered capsule Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




Primary Outcome Measures :
  1. The number of subjects from which we will be able to collect biopsy samples using IVLCM technique [ Time Frame: 5 months ]
    We will measure the number of subjects from which we will be able to collect biopsy samples using IVLCM technique



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830801


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Principal Investigator: Gary Tearney, MD., PhD Massachusetts General Hospital

Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03830801     History of Changes
Other Study ID Numbers: 2017-P-001752
5R01EB022077-02 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases