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Pharmacodynamic Analyses of Metabolic Agents Following Brain Radiation

NCT05720624 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-10-22

No results posted yet for this study

Summary

This phase I trial studies the impact of taking drugs (agents) that target altered brain metabolism following standard of care brain radiotherapy. Radiotherapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. However, radiotherapy can also cause harmful effects to normal brain functioning. One drug, called anhydrous enol-oxaloacetate (AEO), has previously been studied in ischemic stroke, Alzheimer's disease, Parkinson's disease, and glioma. Drugs such as AEO may help preserve or restore healthy brain function after brain radiotherapy compared to the standard practice which consists of no drugs.

Conditions

  • Malignant Central Nervous System Neoplasm

Interventions

DRUG

Anhydrous Enol-oxaloacetate

Given PO

OTHER

Best Practice

Receive standard of care therapy

PROCEDURE

Biospecimen Collection

Undergo collection of CSF and blood

PROCEDURE

Magnetic Resonance Spectroscopic Imaging

Undergo MRS imaging

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Terence C. Burns, MD, PhD · Mayo Clinic in Rochester

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2025-10-20
Completion
2025-10-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720624 on ClinicalTrials.gov