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NOT YET RECRUITING
NCT06732388
PHASE2

Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Endoscopic Procedure

Undergo endoscopy

DRUG

Itraconazole

Given PO

DRUG

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

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