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Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

Primary Purpose

Barrett's Esophagus

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proflavine, high resolution imaging
Sponsored by
Anandasabapathy, Sharmila, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Barrett's Esophagus focused on measuring Barrett's esophagus, proflavine, Microscopic imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Proflavine, high resolution imaging

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
Compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions

Secondary Outcome Measures

The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia.
To be determined using histopathologic diagnosis of mucosal biopsise as the reference standard

Full Information

First Posted
December 9, 2013
Last Updated
January 12, 2021
Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
William Marsh Rice University, Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02018367
Brief Title
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
Official Title
Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anandasabapathy, Sharmila, M.D.
Collaborators
William Marsh Rice University, Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Primary outcomes: the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy - compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR) the total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary? Secondary outcomes: sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard) the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (< 3 cm and > 3cm)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Barrett's esophagus, proflavine, Microscopic imaging

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proflavine, high resolution imaging
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Proflavine, high resolution imaging
Other Intervention Name(s)
Proflavine hemisulfate
Intervention Description
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 Information:
Title
The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
Description
Compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia.
Description
To be determined using histopathologic diagnosis of mucosal biopsise as the reference standard
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
The clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia
Description
Does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR) The total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary?
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmila Anandasabapathy, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeleine Allman, MPH
Phone
713-798-7585
Email
madeleine.allman@bcm.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
26253018
Citation
Shin D, Lee MH, Polydorides AD, Pierce MC, Vila PM, Parikh ND, Rosen DG, Anandasabapathy S, Richards-Kortum RR. Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2016 Jan;83(1):107-14. doi: 10.1016/j.gie.2015.06.045. Epub 2015 Aug 5.
Results Reference
derived

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Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

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