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Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus
Sponsor: National Cancer Institute (NCI)
Summary
This phase II trial tests how well itraconazole works in combination with the usual standard of care endoscopy with ablation for the prevention of esophageal cancer in patients who have high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes and becomes more like the tissue that lines the intestine. People with Barrett's esophagus have a higher risk of developing esophageal cancer. Itraconazole is a drug used to prevent or treat fungal infections. Ablation refers to the removal of abnormal tissue using heat. Endoscopy is a procedure for looking at the esophagus using a long, flexible tube called an endoscope, which has a video camera at the end. Radiofrequency ablation is a type of heat therapy that uses radiofrequency energy (similar to microwave heat) to destroy the abnormal tissue in the esophagus. Giving itraconazole in combination with standard of care endoscopy with ablation may improve the effects of ablation and prevent esophageal cancer in patients with high-risk Barrett's esophagus.
Official title: Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-Risk Barrett's Esophagus in Combination With Ablation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2026-02-16
Completion Date
2028-01-02
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Biopsy Procedure
Undergo tissue biopsy
Biospecimen Collection
Undergo blood sample collection
Endoscopic Procedure
Undergo endoscopy
Itraconazole
Given PO
Placebo Administration
Given PO
Questionnaire Administration
Ancillary studies
Radiofrequency Ablation
Undergo radiofrequency ablation
Locations (6)
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Baylor University Medical Center
Dallas, Texas, United States