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

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.

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 data supports the effectiveness of the treatment Artificial Intelligence Mobile High-Resolution Microendoscope, Proflavine Hemisulfate for esophageal cancer?

Research shows that optical biopsy technologies, which include high-resolution imaging techniques, can effectively identify early signs of cancer in the esophagus and other organs. Additionally, AI-assisted systems have demonstrated high accuracy in detecting early esophageal cancer, suggesting that combining these technologies could improve early diagnosis and treatment outcomes. ^{1 2 3 4 5}

Is Optical Biopsy Technology for Esophageal Cancer safe for humans?

The research does not provide specific safety data for Optical Biopsy Technology, but it discusses the use of artificial intelligence and high-resolution microendoscopy in diagnosing esophageal conditions, which suggests these technologies are being actively studied and used in clinical settings. ^{2 5 6 7 8}

How does the Artificial Intelligence Mobile High-Resolution Microendoscope treatment for esophageal cancer differ from other treatments?

This treatment is unique because it uses advanced optical biopsy technology to provide real-time, high-resolution images of the esophagus at a cellular level, allowing for immediate diagnosis without the need for traditional tissue removal and processing. This approach can potentially improve the accuracy and speed of detecting early cancerous changes compared to conventional methods. ^{1 3 9 10 11}

Research Team

Sharmila Anandasabapathy, MD

Principal Investigator

Baylor College of Medicine

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Optical endomicroscopy and the road to real-time, in vivo pathology: present and future. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Digestive Endoscope Based on Artificial Intelligence System in Diagnosing Early Esophageal Carcinoma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Fluorescence spectroscopy incorporated in an Optical Biopsy System for the detection of early neoplasia in Barrett's esophagus. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Clinical Translation of Tethered Confocal Microscopy Capsule for Unsedated Diagnosis of Eosinophilic Esophagitis. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Accuracy of artificial intelligence-assisted detection of esophageal cancer and neoplasms on endoscopic images: A systematic review and meta-analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Novel Endoscopic Techniques for the Detection of Barrett's Dysplasia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Automated software-assisted diagnosis of esophageal squamous cell neoplasia using high-resolution microendoscopy. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Optical Biopsy of Dysplasia in Barrett's Oesophagus Assisted by Artificial Intelligence. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Near-infrared probe-based confocal microendoscope for deep-tissue imaging. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Label-free multi-photon imaging of dysplasia in Barrett's esophagus. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Detection and treatment of dysplasia in Barrett's esophagus: a pivotal challenge in translating biophotonics from bench to bedside. [2019]