Clinical trialNCT06435286RecruitingPhase 2Interventional

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

SponsorBaylor College of MedicineEnrollment200Prior History of Squamous Cell Dysplasia and /or NeoplasiaSuspected or Known Squamous Cell Neoplasia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Mimi C Tan, MD, MPH
Baylor College of Medicine
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil

Hospital de Cancer de Barretos - Fundacao Pio Xii
Barretos, São Paulo, Brazil
Claudio Hashimoto, MD, MBAElisa R Baba, MD, PhD
Recruiting
Instituto Do Câncer Do Estado de São Paulo
São Paulo, São Paulo, Brazil
Evandro Sobroza de Mello, MDFauze Maluf-Filho, MD
Recruiting

United States

Baylor St. Luke'S Medical Center
Houston, Texas, United States
Mimi C Tan, MD, MPH
Recruiting
Ben Taub Hospital (harris Health Systems)
Houston, Texas, United States
Mimi C Tan, MD, MPH
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Proflavine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Feb 2025
Primary completion: 1 Mar 2027
Completion: 1 Mar 2027
Last update posted: 2 Mar 2026
Registered enrollment: 200
Registry id: NCT06435286

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.