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NOT YET RECRUITING
NCT07694089
PHASE2

Steroid Avoidance, Dexamethasone, and RAGE Inhibition for Perioperative Cerebral Edema Management in High-Grade Gliomas

Sponsor: Akshitkumar MIstry

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn whether two alternatives to standard steroid treatment can safely control swelling around a brain tumor after surgery. The study will compare three approaches by placing participants in one of three study groups: standard dexamethasone (a steroid), no routine steroid treatment, and azeliragon, a study drug that may reduce brain swelling through a different pathway. Researchers want to determine whether these alternatives can control swelling while reducing some of the side effects associated with steroid use. Participants in this study will be randomly assigned to one of three study groups. Participants will undergo their planned brain tumor surgery and receive the treatment assigned to their group. Study procedures are the same as their routine care and include physical and neurological examinations, blood tests, MRI scans, review of medical records, and collection of tumor tissue removed during surgery (optional). Most study visits will occur during routine medical care. Participants will be followed for approximately 24 months after surgery.

Official title: A Randomized Trial of Steroid Avoidance, Dexamethasone, and RAGE Inhibition for Perioperative Cerebral Edema Management in High-Grade Gliomas

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-10-01

Completion Date

2029-08-01

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

Potent FDA-approved corticosteroid

DRUG

Azeliragon

orally bioavailable inhibitor of the receptor for advanced glycation endproducts (RAGE)

Locations (2)

UofL Health Brown Cancer Center; University of Louisville Hospital

Louisville, Kentucky, United States

UofL Health Jewish Hospital

Louisville, Kentucky, United States