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

NCT02018367 | Unknown Phase 2 DMC

• 1 other identifier: GCO #12-0289, H-36538
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Barrett's esophagus; proflavine; Microscopic imaging

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (1)

• The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia.

  1 day

Other Outcomes (1)

• The clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia

  1 day

Study Arms (2)

Proflavine, high resolution imaging

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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 DRUG

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.

Also known as: Proflavine hemisulfate

Proflavine, high resolution imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anandasabapathy, Sharmila, M.D.: lead
• William Marsh Rice University: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 26253018 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Proflavine

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sharmila Anandasabapathy, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 23, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1)