Study on the Effectiveness of Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States

Sponsor: Baylor College of Medicine

Sponsor score: 60

ClinicalTrials ID:NCT06435286

Provider View

This clinical trial is testing a new optical biopsy technology to improve the detection of esophageal cancer in patients in Brazil and the United States. The study aims to see if this technology, combined with artificial intelligence, can help doctors better identify cancerous changes in the esophagus.

Patient Parameters

Program Overview

This study is exploring a new technology called a mobile, high-resolution microendoscope (mHRME) that uses artificial intelligence (AI) to help detect esophageal cancer. The technology was previously tested in China and the US, showing promising results in improving cancer detection. Now, researchers are testing it in Brazil and the US to see if it can help doctors more accurately identify cancerous changes in the esophagus, especially in diverse populations. The study will compare the effectiveness of this technology with traditional methods and evaluate its potential impact on patient care.

Description

The study is testing a new technology that uses a special camera and AI to help doctors find cancer in the esophagus more accurately. This technology, called AI-mHRME, is being tested in Brazil and the US to see if it can improve cancer detection compared to traditional methods. The study has two main goals:

  1. To see if the AI-mHRME can help doctors, especially those with less experience, detect cancer as accurately as experts. The study will involve 200 high-risk patients undergoing standard screening, followed by the AI-mHRME test. Researchers will compare the results from the AI-mHRME with traditional methods to see if it reduces the need for biopsies and additional procedures.

  2. To understand how easy it is to use this new technology in real-world settings. The study will involve discussions with healthcare professionals and patients in both countries to identify any challenges or benefits of using AI-mHRME. This will include interviews and surveys with doctors, patients, and healthcare leaders to gather their opinions and experiences.

The study aims to improve the accuracy and efficiency of esophageal cancer detection, potentially leading to better patient outcomes and fewer unnecessary procedures.

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing routine screening for esophageal cancer using a method called Lugol's chromoendoscopy.
  • Patients with a history of head or neck cancer, heavy smoking, alcohol use, or other risk factors.
  • Patients aged 18 and older.
  • Patients of any gender.
  • Patients who can understand and agree to participate in the study by signing a consent form.

Exclusion Criteria

  • Patients allergic to a specific dye used in the procedure.
  • Patients who cannot understand or agree to participate in the study.
  • Patients with advanced esophageal cancer or large cancerous lesions that cannot be treated with endoscopy.
  • Patients who cannot undergo the standard endoscopy procedure due to medical reasons.
  • Pregnant or breastfeeding women.
  • Patients with certain blood clotting issues or severe medical conditions that make the procedure unsafe.

Locations

FACILITYZIPCITYSTATE
Baylor St. Luke's Medical Center77030HoustonTexas
Ben Taub Hospital (Harris Health Systems)77030HoustonTexas

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