What is this study trying to find out about esophageal squamous cell neoplasia?

This study is evaluating how well an artificial intelligence (AI) mobile high-resolution microendoscope (mHRME) can improve the accuracy and efficiency of esophageal cancer screening. Researchers want to see if AI assistance helps doctors better identify abnormal tissues compared to standard screening methods. The study is sponsored by Baylor College of Medicine and includes participants from Brazil and the United States.

Who may be eligible for this esophageal cancer clinical trial?

Adults aged 18 years or older who are undergoing routine Lugol's chromoendoscopic screening for squamous cell neoplasia may be eligible. Participants of any sex or gender can join if they can give informed consent. People allergic to the dye proflavine hemisulfate or unable to undergo endoscopy with biopsy may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this esophageal cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06435286

Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening A Clinical Study in Brazil and the United States

Led by Baylor College of Medicine · Updated on 2026-03-02

200

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effectiveness of an artificial intelligence AI mobile, high-resolution microendoscope mHRME combined with Lugols chromoendoscopy LCE to improve the detection and diagnosis of esophageal squamous cell neoplasia ESCN in diverse populations in Brazil and the United States. This Phase 2 clinical trial builds on previous studies showing that AI-mHRME may improve diagnostic accuracy and reduce unnecessary biopsies, especially among less experienced clinicians. The study aims to evaluate the diagnostic performance, efficiency, and clinical impact of this new technology compared to standard procedures. All participants will undergo standard white light imaging WLI and Lugols chromoendoscopy LCE as usual care. After LCE, the AI-mHRME device will be used to image both abnormal and normal areas of the esophagus. Proflavine hemisulfate, a fluorescent dye, will be sprayed on the esophageal lining to enhance imaging. The AI software will analyze images, and clinicians will record their readings, confidence levels, and biopsy or treatment decisions before and after AI assistance. Biopsies will be taken from abnormal areas for expert pathological evaluation. Participants will be involved in routine screening visits where clinical decisions and imaging results will be documented. Researchers will measure the AI-mHRMEs impact on clinical decisions, procedure efficiency, diagnostic accuracy, and clinician confidence over an 18-month period. Additional studies will gather feedback from healthcare providers, patients, and stakeholders to understand potential barriers and supports for implementing this technology in different healthcare settings. Overall participation duration varies by individual screening schedules within the study timeline.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Outpatients undergoing routine Lugol's chromoendoscopic screening for squamous cell neoplasia, including those with a history of head/neck squamous cell cancer, heavy smoking or alcohol use, dietary or geographic risk factors, or prior dysplasia
Patients 18 years old or older
Patients of any sex or gender
Patients willing and able to give informed consent

You will not qualify if you...

Allergy or prior reaction to proflavine hemisulfate
Unable to give informed consent
Known advanced squamous cell carcinoma of the distal esophagus or malignant esophageal lesion 2 cm or larger not treatable by endoscopy
Unable to undergo routine endoscopy with biopsy
Pregnant or breastfeeding women
Prothrombin time greater than 50% of control, PTT greater than 50 seconds, or INR greater than 2.0
Cardio-pulmonary instability or other significant medical issues preventing sedated upper endoscopy

Research Team

Mimi C Tan, MD, MPH

Adrianna O Maliga, MPH

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here