RecruitingPhase 2NCT06732388

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

Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-risk Barrett's Esophagus in Combination With Ablation


Sponsor

National Cancer Institute (NCI)

Enrollment

76 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Biopsy Procedure, a procedure called Biospecimen Collection, and others for people with barrett esophagus, clinical stage i esophageal adenocarcinoma ajcc v8, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREEndoscopic Procedure

Undergo endoscopy

DRUGItraconazole

Given PO

DRUGPlacebo Administration

Given PO

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURERadiofrequency 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

View Full Details on ClinicalTrials.gov

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NCT06732388


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