Using AI technology to improve esophageal cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.