RecruitingPhase 2NCT06435286

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

Sponsor

Baylor College of Medicine

Enrollment

200 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new technology called optical biopsy — a light-based imaging tool used during an endoscopy (a camera procedure down the throat) — to detect early esophageal cancer or pre-cancerous changes more accurately in Brazil and the United States. **You may be eligible if...** - You are over 18 years old - You are already scheduled for a routine Lugol's chromoendoscopy screening (a standard test for esophageal squamous cell cancer) - You are being screened because of risk factors such as a history of head or neck cancer, heavy smoking or alcohol use, prior abnormal findings, or dietary or geographic risk factors - You are willing and able to give informed consent **You may NOT be eligible if...** - You have an allergy or previous reaction to the contrast agent proflavine hemisulfate used in the optical biopsy - You cannot give informed consent - You have known advanced squamous cell cancer of the lower esophagus, or a suspicious/cancerous esophageal lesion 2 cm or larger that cannot be treated with endoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProflavine Hemisulfate

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

DEVICEArtificial 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.

Locations(4)

Baylor St. Luke's Medical Center

Houston, Texas, United States

Ben Taub Hospital (Harris Health Systems)

Houston, Texas, United States

Hospital de Cancer de Barretos - Fundacao Pio XII

Barretos, São Paulo, Brazil

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

View Full Details on ClinicalTrials.gov

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NCT06435286