GlioblastomaEarly Phase 1NCT07387666
Imaging Acetadote Metabolism in Glioblastoma
A Early Phase 1 study testing Acetadote in people with Glioblastoma and GBM, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, GBM
- What is being tested?
- Acetadote
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 1 Jul 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- - 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Omar Raslan, MBBCH, MPH, CCRP, Omar.Raslan@UTSouthwestern.edu
214-648-7097
About this study
Official title: 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.
- Conditions
- Glioblastoma, GBM
- Being tested
- Acetadote
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetadoteDrug
Acetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Acetadote 150 mg/kg IV | Experimental | 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. Receives: Drug: Acetadote |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and up to 21 days from Day 1
Secondary outcomes (1)
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).
Measured: Day 1 and up to 21 days from Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start18 Jun 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cumberland Pharmaceuticals
- Responsible party
- Principal investigator, Evan Noch, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387666
- Sponsor's protocol ID
- STU20250529; SCCC-07325
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT07387666
- Acronym / sponsor ID
- STU20250529; SCCC-07325
- Conditions
- Glioblastoma, GBM
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Cumberland Pharmaceuticals
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acetadote 150 mg/kg IV | Experimental | Drug: AcetadoteAcetadote 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetadoteAcetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour | Drug | Acetadote 150 mg/kg IV |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acetadote in people with Glioblastoma and GBM, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Raslan, MBBCH, MPH, CCRP (214-648-7097, omar.raslan@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.