Actively Recruiting
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
Led by Baylor College of Medicine · Updated on 2026-03-02
200
Participants Needed
4
Research Sites
106 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
W
William Marsh Rice University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients undergoing routine Lugol's chromoendoscopic screening for squamous cell neoplasia, including those with history of head/neck squamous cell cancer, heavy smoking, alcohol use, or prior dysplasia
- Patients older than 18 years
- 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
- Patients unable to give informed consent
- Known advanced squamous cell carcinoma of the distal esophagus or lesion 2 cm or larger not suitable for endoscopic therapy
- Inability to undergo routine endoscopy with biopsy
- Women who are pregnant or breastfeeding
- Prothrombin time greater than 50% of control, PTT greater than 50 seconds, or INR greater than 2.0
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other serious medical issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Ben Taub Hospital (Harris Health Systems)
Houston, Texas, United States, 77030
Actively Recruiting
3
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
4
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000
Actively Recruiting
Research Team
M
Mimi C Tan, MD, MPH
CONTACT
A
Adrianna O Maliga, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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