Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07387666

Imaging Acetadote Metabolism in 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Evan Noch, MD, PhD

PRINCIPAL_INVESTIGATOR

Omar Raslan, MBBCH, MPH, CCRP

CONTACT

[email protected]

CONTACT

214-648-7097

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetadote

Drug

Acetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour

Primary outcomes

  1. To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS.

    Time frame: Day 1 and up to 21 days from Day 1

    The effect of Acetadote on glioblastoma metabolism will be assessed by measuring cysteine, glutathione, and lactate in glioblastoma through MRS.

Secondary outcomes

  1. To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by LCMS

    Time frame: Day 1 and up to 21 days from Day 1

    The effect of Acetadote on glioblastoma metabolism in resected tumor tissue will be measured by Liquid chromatography-mass spectrometry (LCMS).

Study contacts

Contact information is provided by the study sponsor or research team.

Omar Raslan, MBBCH, MPH, CCRP

CONTACT

[email protected]

214-648-7097

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Cumberland Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.