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Device

Optical Biopsy Technology for Esophageal Cancer

Phase 2

Waitlist Available

Led By Sharmila Anandasabapathy, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients >18 years old

Be older than 18 years old

Must not have

Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues

Patients who are unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tested a new device called a mobile, high-resolution microendoscope (mHRME) in China and the US to screen for a type of esophageal cancer. The device was found

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include allergic reactions to proflavine hemisulfate used as a fluorescent contrast agent during the procedure. There might also be general risks associated with sedated upper endoscopy such as discomfort or complications from sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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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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I cannot have a standard endoscopy with biopsy.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Impact

Clinician Confidence

Performance Characteristics

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proflavine Hemisulfate

2009

Completed Phase 2

~210

0 / 6Eligibility criteria met