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An Artificial-Intelligence Mobile High-Resolution Microendoscope for the Screening of Esophageal Cancer
Trial Status: active
This phase II trial studies how well an artificial-intelligence mobile high-resolution microendoscope (AI-mHRME) works for the screening of esophageal cancer. Upper endoscopy is often used during screening for esophageal cancer. It is a procedure that places a long, bendable tube with a light and camera (probe) down the throat to check the esophagus. During an endoscopy using an AI-mHRME, a powerful microscope is used to take pictures of areas of the esophagus that may be of concern. The microscope is linked to artificial intelligence (AI). AI is a computer software program that can perform human tasks. It identifies and assists doctors in finding abnormal cells. A staining dye called proflavine hemisulfate (proflavine) is also used to dye the esophagus where any abnormal areas are identified to help doctors better see the cells when the probe is against the esophageal lining. Using an AI-mHRME during screening endoscopy may be an effective way to identify esophageal cancer.
Inclusion Criteria
Patients scheduled for endoscopy procedures at the following sites:
* Baylor St. Luke’s Medical Center (BSLMC), Houston, Texas, United States (US)
* Harris Health Systems Ben Taub General Hospital (BTH), Houston, Texas, US
* Instituto do Câncer de Estado de Saõ Paulo (ICESP), Saõ Paulo, Saõ Paulo State, Brazil
* Barretos Cancer Center/Hospital de Amor (BCC), Barretos, Saõ Paulo State, Brazil
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent per institutional and federal guidelines
Patients undergoing routine (standard of care) LCE screening for esophageal squamous cell carcinoma (ESCC)
* Patients with known history of head/neck squamous cancer (e.g., laryngeal and hypopharyngeal cancer, nasal cavity and paranasal sinus cancer, nasopharyngeal cancer, oral and oropharyngeal cancer, or salivary gland cancer)
* Heavy smoking and/or alcohol use
* Dietary or geographic risk factors for ESCC
Patients undergoing follow-up surveillance for ESCC (e.g., prior low-grade dysplasia or indefinite for dysplasia)
Patients are 18 years or older
Patients who have never been enrolled in a study with AI-mHRME and proflavine hemisulfate
Exclusion Criteria
Allergy or prior reaction to proflavine or iodine
Current active esophageal cancer not amenable to endoscopic therapy
The patient is unable to undergo routine endoscopy with biopsy
* Women who are pregnant or breastfeeding
* Prothrombin time (PT) greater than 50% of control; prothrombin time test (PTT) greater than 50 seconds (sec), or international normalized ratio (INR) greater than 2.0
* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
* Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endoscope
* Patients who have previously been enrolled in a study with AI-mHRME and proflavine hemisulfate
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06435286.
Locations matching your search criteria
United States
Texas
Houston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
I. To evaluate the specificity among novices using AImHRME during esophageal cancer screening and
surveillance.
SECONDARY OBJECTIVES:
I. To assess the diagnostic performance of AImHRME.
II. To evaluate provider confidence (experts and novices) in clinically interpreting mHRME (pre- and post-use of AI-mHRME).
III. To assess the clinical impact following AI-mHRME.
IV. To determine the diagnostic yield of AI-mHRME.
V. To determine procedure efficiency of AI-mHRME, including subjects saved any biopsy and biopsy efficiency.
OUTLINE:
Patients receive proflavine topically to the esophageal mucosa via spray catheter and then undergo high-resolution microendoscopy (HRME) using AI-mHRME during standard of care (SOC) Lugol’s chromoendoscopy (LCE). Patients also undergo esophageal biopsy on study.
After completion of study intervention, patients are followed up at 7 and 180 days.
Trial PhasePhase II
Trial Typescreening
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
