Optical Biopsy Technology for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen bySharmila Anandasabapathy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for outpatients over 18 years old who need routine screening for esophageal squamous cell neoplasia, which can be due to a history of related cancers, smoking, alcohol use, or dietary risks. It's not for those unable to consent, pregnant/breastfeeding women, patients with advanced cancer lesions >2cm not treatable by endoscopy, or those with certain blood clotting and sedation risks.

Inclusion Criteria

I am over 18 years old.

My sex or gender does not limit my participation.

Patients who are willing and able to give informed consent

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Exclusion Criteria

I cannot undergo sedated upper endoscopy due to heart or lung problems.

I am able to understand and agree to the study's procedures and risks.

I have advanced cancer or a large, suspicious lesion in the lower part of my esophagus that can't be treated with a scope.

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Treatment Details

Interventions

Artificial Intelligence Mobile High-Resolution Microendoscope (Device)
Proflavine Hemisulfate (Other)

Trial OverviewThe study tests an AI-enhanced mobile high-resolution microendoscope (AI-mHRME) against the standard Lugol's chromoendoscopy in detecting esophageal cancer. The technology uses artificial intelligence and a fluorescent contrast agent to improve diagnosis accuracy in diverse populations in Brazil and the US.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imagingExperimental Treatment2 Interventions

All subjects will receive White Light Imaging (WLI) and Lugol's Chromoendoscopy (LCE), the current standard of care (SOC) procedure. Following LCE, all subjects will receive the artificial intelligence (AI) mobile high-resolution microendoscopy (mHRME) imaging with Proflavine Hemisulfate of any LCE abnormal and LCE normal areas (4:1 ratio). For both WLI and LCE, we will record the subjective clinician read (neoplastic, non-neoplastic), the confidence level in their diagnoses (high, low), and the action plan (biopsy vs. no biopsy vs. treat). With the AI-mHRME, we will image the same LCE abnormal and normal areas and record the software read, the clinician confidence level, and action plan. Finally, the imaged LCE abnormal areas will be biopsied or resected, and evaluated by a pathologist.