Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 17, 2025

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2027

Conditions
Suspected or Known Squamous Cell NeoplasiaPrior History of Squamous Cell Dysplasia and /or Neoplasia
Interventions
DRUG

Proflavine Hemisulfate

Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.

DEVICE

Artificial Intelligence Mobile High-Resolution Microendoscope

The AI-mHRME will be inserted through the endoscope biopsy channel and gently placed against the mucosa where proflavine was sprayed. The probe will transmit images to the computer/laptop for the clinician to observe any abnormal tissues and save photos of these tissues.

Trial Locations (4)

77030

RECRUITING

Baylor St. Luke's Medical Center, Houston

RECRUITING

Ben Taub Hospital (Harris Health Systems), Houston

14784-400

RECRUITING

Hospital de Cancer de Barretos - Fundacao Pio XII, Barretos

01246-000

RECRUITING

Instituto do Câncer do Estado de São Paulo, São Paulo

All Listed Sponsors
collaborator

William Marsh Rice University

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

collaborator

Hospital de Cancer de Barretos - Fundacao Pio XII

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Baylor College of Medicine

OTHER