Recruiting
Phase 2

HRME

Sponsor:

Anandasabapathy, Sharmila, M.D.

Code:

NCT02018367

Conditions

Barrett's Esophagus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proflavine, high resolution imaging

Study Details

Brief summary:

The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).

Conditions

Barrett's Esophagus

Study ID

NCT02018367

Start date

Sep, 2012

Status verified date

Jan, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • outpatients with > 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.

Exclusion Criteria:

  • Allergy or prior reaction to the fluorescent contrast agent proflavine
  • Patients who are unable to give informed consent.
  • Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion > 2 cm in size not amenable to EMR
  • Patients with a history of a severe allergic reaction (anaphylaxis)
  • Patients unable to undergo routine endoscopy with biopsy :
  • Women who are pregnant or breastfeeding
  • Prothrombin Time > 50% of control; PTT > 50 sec, or INR > 2.0)
  • Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other
  • Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope
  • Patients with known severe esophagitis
  • Patients with suspected but no biopsy confirmed BE

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Proflavine, high resolution imaging

Proflavine hemisulfate will be used as a topical contrast agent in conjunction with the high resolution imaging device to visualize and image areas suspicious for neoplasia. Biopsies will be taken per Seattle biopsy protocol for Barrett's Esophagus surveillance.

no intervention: Standard of care

Standard of care examination of the upper GI tract using the standard high resolution endoscope with bipsies taken per Seattle biopsy protocol for Barrett's Esophagus surveillance.

Interventions

Proflavine, high resolution imaging

5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy.

Primary outcome measure

  • The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy [ Time Frame: 1 day ]

Central Contacts and Locations

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Madeleine Allman, MPH

713-798-7585madeleine.allman@bcm.edu

More Information

Sponsor

Anandasabapathy, Sharmila, M.D.

Last update posted

Jan 14, 2021

Last verified

Jan, 2021

Keywords

  • Barrett's esophagus
  • proflavine
  • Microscopic imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anandasabapathy, Sharmila, M.D. on 2021-01-14.