MedTrace Logo

Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States

NCT06435286 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-02

No results posted yet for this study

Summary

In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p \<0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.

Conditions

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

Interventions

DRUG

Proflavine Hemisulfate

Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.

DEVICE

Artificial Intelligence Mobile High-Resolution Microendoscope

The AI-mHRME will be inserted through the endoscope biopsy channel and gently placed against the mucosa where proflavine was sprayed. The probe will transmit images to the computer/laptop for the clinician to observe any abnormal tissues and save photos of these tissues.

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Instituto do Cancer do Estado de São Paulo

    collaborator OTHER

  • Hospital de Cancer de Barretos - Fundacao Pio XII

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Mimi C Tan, MD, MPH · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06435286 on ClinicalTrials.gov