High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia

January 12, 2021 updated by: Anandasabapathy, Sharmila, M.D.

High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: A Randomized, Multicenter Trial of Accuracy, Yield, and Clinical Impact

The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides >1000X magnified images of the esophageal mucosa.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Our central hypothesis is that HRME can improve the efficiency and clinical impact of endoscopic screening and surveillance of esophageal squamous cell neoplasia by providing in-vivo optical biopsies comparable to standard histology. Specifically, HRME will allow more detailed evaluation of Lugol's abnormal areas, allowing selective biopsy or removal of neoplastic mucosa. We hypothesize that this will improve the accuracy and diagnostic yield of mucosal sampling.

We also hypothesize the HRME will provide additional, more accurate information regarding the presence of neoplasia that will impact upon the physician's decision to obtain a mucosal biopsy or perform endoscopic therapy (endoscopic mucosal resection or ablation). This could potentially minimize the number of unnecessary biopsies and enable the physician to perform endoscopic therapy at the time of the initial examination, rather than delaying endoscopic treatment to another procedure following pathologic confirmation of the initial biopsies.

Primary Aims:

  1. To compare the efficiency of HRME + Lugol's chromoendoscopy (HRME + LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia. Efficiency will be defined as:

    1. Diagnostic Yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who receive biopsies.
    2. 'Patients saved': # patients who receive no biopsies
    3. Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
  2. To prospectively determine the potential clinical impact of HRME + Lugol's chromoendoscopy (HRME-LC) to Lugol's Chromoendoscopy (LC) by determining if HRME changes the decision to perform endoscopic therapy (endoscopic mucosal resection or ablation) or perform a mucosal biopsy.

  3. To prospectively compare the performance characteristics of HRME-LC to LC for the prediction of squamous esophageal neoplasia in flat mucosa and mucosal lesions using histopathology as the gold standard:

    (a) To determine the sensitivity, specificity, positive and negative predictive value for the identification of neoplasia on a per biopsy and per patient analysis

  4. To determine the cost-effectiveness of HRME-LC to LC alone for the endoscopic screening and surveillance of esophageal squamous neoplasia in the US and China.

Study Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Madeleine Allman, MPH
  • Phone Number: 713-798-7585
  • Email: allman@bcm.edu

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS)
        • Principal Investigator:
          • Guiqi Wang
        • Contact:
    • Jilin
      • Changchun, Jilin, China
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Sharmila Anandasabapathy, MD

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.

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:

All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing patients referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group.

Exclusion Criteria:

  • Allergy or prior reaction to the fluorescent contrast agent proflavine
  • Patients who are unable to give informed consent
  • Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy
  • Patient unable to undergo routine endoscopy with biopsy:
  • women who are pregnant or breastfeeding
  • prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0
  • inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Proflavine, high resolution imaging
5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.
Drug: Proflavine, high resolution imaging
5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.
Other Names:
  • Proflavine hemisulfate
NO_INTERVENTION: Standard of care
No invention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia.
Time Frame: 1 day

Efficiency

  1. Diagnostic yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.
  2. 'Patient saved': # of patients who received no biopsies
  3. Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy
Time Frame: 1 day
Clinical Impact
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the performance characteristics of HRME to LC for the prediction of squamous esophageal neoplasia using histopatholgy as the gold standard. The cost-effectiveness of HRME-LC to LC alone.
Time Frame: 1 day
Cost-effectiveness
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anandasabapathy, Sharmila, M.D.

Collaborators

Baylor College of Medicine
William Marsh Rice University

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 Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

January 7, 2014

First Posted (ESTIMATE)

January 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 13-0396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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