Optical Biopsy Technology for Esophageal Cancer

Recruiting at 3 trial locations

Overseen By Sharmila Anandasabapathy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baylor College of Medicine

Disqualifiers: Allergy to proflavine, Advanced carcinoma, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology that uses artificial intelligence to detect early signs of esophageal cancer. The goal is to determine if this tool can improve the accuracy of cancer screenings and enhance treatment plans. Participants will undergo both standard screening methods and the new AI-assisted screening using the Artificial Intelligence Mobile High-Resolution Microendoscope. Individuals already undergoing routine screenings for esophageal issues, particularly those with a history of heavy smoking or head/neck cancer, might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in early cancer detection.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this optical biopsy technology is safe for esophageal cancer screening?

Research has shown that the Artificial Intelligence Mobile High-Resolution Microendoscope (AI-mHRME) has been tested in earlier studies for assessing esophageal conditions. In these studies, it was used alongside standard methods to enhance the detection of abnormal tissue. The AI-mHRME has shown promise in improving diagnostic accuracy without causing major side effects.

Although detailed safety data from these studies are limited, the trial's phase 2 status indicates that initial tests demonstrated general safety for participants. Treatments typically reach this phase only after proving safe in earlier, smaller studies, suggesting no major safety concerns have arisen so far.

For those considering participation in a trial with this technology, this information may provide reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the Artificial Intelligence Mobile High-Resolution Microendoscope (AI-mHRME) for esophageal cancer because it offers a new way to enhance diagnostic accuracy. Unlike the standard approach, which relies on White Light Imaging (WLI) and Lugol's Chromoendoscopy (LCE) to identify abnormal areas, the AI-mHRME uses advanced imaging technology combined with artificial intelligence to provide a more detailed view of the esophageal tissue. This technology allows for a more precise distinction between neoplastic (cancerous) and non-neoplastic (non-cancerous) areas, potentially leading to better-targeted biopsies and treatments. By improving the confidence in diagnoses and reducing unnecessary biopsies, the AI-mHRME could significantly enhance patient outcomes in esophageal cancer care.

What evidence suggests that this trial's treatments could be effective for esophageal cancer?

Research has shown that using a mobile, high-resolution microendoscope (mHRME) can significantly enhance the screening process for esophageal squamous cell neoplasia (ESCN), a type of esophageal cancer. Previous studies increased the success rate of detecting cancerous tissue during biopsies from 8% to 29%. Additionally, 16% of patients were correctly identified as not needing a biopsy, and 18% had their treatment plans improved. In this trial, all participants will receive AI-enhanced mHRME imaging with Proflavine Hemisulfate. Adding artificial intelligence (AI) to mHRME is expected to improve its ability to spot abnormal tissue. Early results from a pilot study in Brazil suggested that AI can help identify cancerous images, making the screening process more efficient. ^{1 2 3 6 7}

Who Is on the Research Team?

Sharmila Anandasabapathy, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

Patients who are willing and able to give informed consent

My sex or gender does not limit my participation.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo White Light Imaging (WLI) and Lugol's Chromoendoscopy (LCE), followed by AI-mHRME imaging for esophageal cancer screening

18 months

Multiple visits as per study protocol

Follow-up

Participants are monitored for changes in clinical plan and clinician confidence post AI-mHRME

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Artificial Intelligence Mobile High-Resolution Microendoscope
• Proflavine Hemisulfate

Trial Overview 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.

How Is the Trial Designed?

Group I: Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Instituto do Cancer do Estado de São Paulo

Collaborator

Trials

91

Recruited

11,600+

Hospital de Cancer de Barretos - Fundacao Pio XII

Collaborator

Trials

4

Recruited

1,400+

William Marsh Rice University

Collaborator

Trials

50

Recruited

28,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39477026/

A High-Resolution Microendoscope Improves Esophageal ... A low-cost microendoscope improves the efficiency and clinical impact of ESCN screening and surveillance when combined with LCE.

2. gastrojournal.org gastrojournal.org/article/S0016-5085%2824%2905643-9/fulltext

A High-Resolution Microendoscope Improves Esophageal ... HRME increased efficiency in screening: diagnostic yield (neoplastic/total biopsies) improved from 20.0% (95% confidence interval [CI], 12.7– ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06435286

Effectiveness and Performance of an Optical Biopsy ... The investigators' hypothesis is that the artificial intelligence (AI) mobile, high-resolution microendoscope (mHRME) will increase the accuracy of Lugol's ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-02808

An Artificial-Intelligence Mobile High-Resolution ... This phase II trial studies how well an artificial-intelligence mobile high-resolution microendoscope (AI-mHRME) works for the screening of esophageal ...

5. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/10931518

Project Details - NIH RePORTER In our ongoing R01 project, we developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of ESCN. Despite ≥2 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510716017661

A tablet-interfaced high-resolution microendoscope with ... In recent years high-resolution microendoscopy (HRME) has shown potential to improve screening for esophageal squamous cell neoplasia.

7. giejournal.org giejournal.org/article/S0016-5107(16)01766-1/abstract

A tablet-interfaced high-resolution microendoscope with ... In recent years high-resolution microendoscopy (HRME) has shown potential to improve screening for esophageal squamous cell neoplasia.