High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia

NCT02029937 | Unknown Phase 2 DMC

• 1 other identifier: GCO 13-0396
• Study Type: interventional
• Target: 1,300
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Suspected or Known Squamous Cell Neoplasia; Prior History of Squamous Cell Dysplasia and /or Neoplasia

Keywords

Squamous cell neoplasia; Proflavine; Lugol's chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy

  1 day

Other Outcomes (1)

• 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.

  1 day

Study Arms (2)

Proflavine, high resolution imaging

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

No invention

Interventions

Proflavine, high resolution imaging DRUG

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.

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:

• 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.

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 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

Sponsors & Collaborators

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

Study Sites (3)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS)

Beijing, China

RECRUITING

Related Publications (1)

• Tan MC, Li Z, Patel KK, Zhang F, Yu X, Wang X, Rosen DG, Dawsey SM, Xue L, Hur C, Schwarz RA, Vohra I, Tang Y, Wu M, Wang T, Carns J, Xu H, Richards-Kortum RR, Wang G, Anandasabapathy S. A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial. Gastroenterology. 2025 Mar;168(3):496-507.e3. doi: 10.1053/j.gastro.2024.10.025. Epub 2024 Oct 29.

  PMID: 39477026 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Proflavine

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

Central Study Contacts

Madeleine Allman, MPH

CONTACT

713-798-7585; allman@bcm.edu

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 17, 2013
• First Posted: January 8, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

US (1); CN (2)