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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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ClinicalTrials.gov Identifier: NCT02018367
Recruitment Status : Recruiting
First Posted : December 23, 2013
Last Update Posted : January 14, 2021
Sponsor:
Collaborators:
William Marsh Rice University
Baylor College of Medicine
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.

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).

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Drug: Proflavine, high resolution imaging Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma
Study Start Date : September 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: 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.
Other Name: Proflavine hemisulfate

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.



Primary Outcome Measures :
  1. The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy [ Time Frame: 1 day ]
    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 :
  1. The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia. [ Time Frame: 1 day ]
    To be determined using histopathologic diagnosis of mucosal biopsise as the reference standard


Other Outcome Measures:
  1. The clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia [ Time Frame: 1 day ]
    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?



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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:

  • 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

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): NCT02018367


Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Madeleine Allman, MPH    713-798-7585    madeleine.allman@bcm.edu   
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
William Marsh Rice University
Baylor College of Medicine
Investigators
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Principal Investigator: Sharmila Anandasabapathy, MD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Anandasabapathy, Sharmila, M.D.:
Informed Consent Form  [PDF] December 14, 2017
Study Protocol  [PDF] December 14, 2017
Statistical Analysis Plan  [PDF] December 14, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT02018367    
Other Study ID Numbers: GCO #12-0289, H-36538
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Keywords provided by Anandasabapathy, Sharmila, M.D.:
Barrett's esophagus
proflavine
Microscopic imaging
Additional relevant MeSH terms:
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Adenocarcinoma
Barrett Esophagus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents