Imaging Acetadote Metabolism in Glioblastoma

A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioblastoma; GBM
• Intervention / Treatment: Drug: Acetadote

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Omar Raslan, MBBCH, MPH, CCRP; Phone Number: 214-648-7097; Email: omar.raslan@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Principal Investigator: Evan Noch, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetadote 150 mg/kg IV; Acetadote will be administered twice during this study: first before undergoing magnetic resonance spectroscopy (MRS) on Day 1 and second before undergoing surgical resection, which will take place between Days 2-21. Acetadote will be administered at a dose of 150 mg/kg IV over 60 minutes.	Drug: Acetadote; Acetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS.	The effect of Acetadote on glioblastoma metabolism will be assessed by measuring cysteine, glutathione, and lactate in glioblastoma through MRS.	Day 1 and up to 21 days from Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by LCMS	The effect of Acetadote on glioblastoma metabolism in resected tumor tissue will be measured by Liquid chromatography-mass spectrometry (LCMS).	Day 1 and up to 21 days from Day 1

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Cumberland Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Amino Acids; Cysteine; Amino Acids, Sulfur; Acetylcysteine
• Other Study ID Numbers: STU20250529; SCCC-07325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes