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

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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell cancer; heavy smoking and alcohol, other dietary or geographic risk factors or prior dysplasia
* Patients \>18 years old.
* Patients of any sex or gender.
* Patients who are willing and able to give informed consent.

Exclusion Criteria:

* Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate.
* Patients who are unable to give informed consent.
* Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in size not amenable to endoscopic therapy.
* Patient unable to undergo routine endoscopy with biopsy:
* Women who are pregnant or breast feeding,
* 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.

About the study

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.

What is being tested

• Proflavine Hemisulfate (drug)
• Artificial Intelligence Mobile High-Resolution Microendoscope (device)

Sponsor: Baylor College of Medicine · Participants: 200 · Started: Feb 17, 2025

Contact the study team

• Mimi C Tan, MD, MPH · Phone: 7137980950
• Adrianna O Maliga, MPH · Phone: (713) 798-5987

Official record on ClinicalTrials.gov — NCT06435286

Locations in the U.S.

Conditions

• Cancer (all types)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.