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NCT07387666EARLY_PHASE1Recruiting

Imaging Acetadote Metabolism in Glioblastoma

University of Texas Southwestern Medical Center

Start Date

6/18/2026

Completion Date

7/1/2028

Summary

This goal of this clinical trial is to evaluate how Acetadote affects metabolism in patients with glioblastoma. Drugs like Acetadote, which affect the level of damage in a cell (oxidative stress), may impact brain tumor metabolism and slow the growth of brain tumors. The investigators are evaluating how Acetadote affects glioblastoma metabolism by using MRI-based methods and by determining the changes in metabolism in brain tumor tissue resected from patients with a new diagnosis of glioblastoma.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 1\. Glioblastoma * 2\. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent * 3\. Age ≥18 years * 4\. KPS \> 70 * 5\. Adequate organ and marrow function as defined below: * \- Bilirubin ≤1.5 times upper limit of normal * \- AST and ALT ≤ 3 times ULN * \- Creatinine ≤ 1.5 x ULN and/or GFR ≤ 60 mL/min * -ANC ≥ 1000 cells/ul * \- Platelet ≥ 100,000/ul * \- Hemoglobin ≥ 9 g/dl * 6\. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * \- Has not undergone a hysterectomy or bilateral oophorectomy; or * \- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * 7\. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * 1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment. * 2\. Subjects must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment). * 3\. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study. * 4\. Brain metastases * 5\. History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote. * 6\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements. * 7\. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Interventions

DRUG

Acetadote

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Conditions

GlioblastomaGBM

Locations

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States