Using AI technology to improve esophageal cancer detection
Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
This study is testing if a new AI tool can help doctors find esophageal cancer more accurately in high-risk patients during routine screenings.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 4 sites (Houston, Texas and 3 other locations) |
| Trial ID | NCT06435286 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an artificial intelligence mobile high-resolution microendoscope (AI-mHRME) combined with Lugol's chromoendoscopy (LCE) for detecting esophageal squamous cell neoplasia in patients at high risk. The study will involve 200 outpatients undergoing routine LCE screening, assessing the diagnostic performance and efficiency of the AI-mHRME compared to traditional methods. The trial aims to enhance the accuracy of cancer detection, particularly among novice clinicians, and reduce unnecessary biopsies. It will also measure clinician confidence and the clinical impact of AI-assisted diagnoses.
Who should consider this trial
Good fit: Ideal candidates include outpatients over 18 years old with a history of squamous cell neoplasia or related risk factors undergoing routine screening.
Not a fit: Patients with advanced squamous cell carcinoma or those unable to undergo routine endoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could lead to earlier and more accurate detection of esophageal cancer, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results with similar AI-assisted diagnostic approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell cancer; heavy smoking and alcohol, other dietary or geographic risk factors or prior dysplasia * Patients \>18 years old. * Patients of any sex or gender. * Patients who are willing and able to give informed consent. Exclusion Criteria: * Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate. * Patients who are unable to give informed consent. * Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in size not amenable to endoscopic therapy. * Patient unable to undergo routine endoscopy with biopsy: * Women who are pregnant or breast feeding, * Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0, * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues.
Where this trial is running
Houston, Texas and 3 other locations
- Baylor St. Luke's Medical Center — Houston, Texas, United States (Recruiting)
- Ben Taub Hospital (Harris Health Systems) — Houston, Texas, United States (Recruiting)
- Hospital de Cancer de Barretos - Fundacao Pio XII — Barretos, São Paulo, Brazil (Recruiting)
- Instituto do Câncer do Estado de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Mimi C Tan, MD, MPH — Baylor College of Medicine
- Study coordinator: Mimi C Tan, MD, MPH
- Email: mc2@bcm.edu
- Phone: 7137980950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.