GlioblastomaPhase 1NCT04019002
Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma
A Phase 1 study testing Hyperpolarized Pyruvate (13C) and Magnetic Resonance Spectroscopic Imaging (MRSI) in people with Glioblastoma and Recurrent Glioblastoma, run by Susan Chang at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment decisions and seeing how well various types of treatment work. The goal is to improve the way patient care is managed in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Recurrent Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- Hyperpolarized Pyruvate (13C) and Magnetic Resonance Spectroscopic Imaging (MRSI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cohort 1: Histologically proven newly diagnosed glioblastoma multiforme (GBM) who will undergo standard of treatment with radiation therapy (RT) and temozolomide (TMZ).
- Cohort 2: Histologically proven recurrent suspected GBM who will receive surgical resection for the recurrence.
- Cohort 3: Histologically proven recurrent suspected GBM who will undergo standard treatment for the recurrence.
- Patients must be >/= 18 years old and with a life expectancy > 16 weeks.
- Patients must have a Karnofsky performance status of ≥ 70.
- Patients must have adequate renal function: creatinine < 1.5 mg/dL before imaging. These tests must be performed within 60 days prior to Hyperpolarized Imaging scan.
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- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.
- Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Patients must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
- Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.
- Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
- Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.
Who cannot join
- Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Evaluating Hyperpolarized and Proton Brain Metabolism in Patients With Glioblastoma
The purpose of this study is to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment decisions and seeing how well various types of treatment work. The goal is to improve the way patient care is managed in the future.
If you chose to be in this study, you will be receiving novel magnetic resonance (MR) metabolic imaging with standard MR imaging. The research component includes an injection of an investigational agent, called hyperpolarized pyruvate 13C, to obtain dynamic metabolic imaging.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluation safety of hyperpolarized (HP) pyruvate (13C) injection for use in imaging lesions in participants with glioblastoma (GBM).
II. To evaluate metabolic changes in tumors and normal-appearing brain tissue in response to standard therapy.
EXPLORATORY OBJECTIVES:
- To evaluate changes in 13C parameters from baseline to the post-RT scan compared in the normal appearing brain, enhancing lesion, non-enhancing lesion and the choline-to-N -acetyl aspartate (NAA) index (CNI) lesion.
II. To evaluate 13C metabolic parameters from the recurrent lesions compared to those in the regions of treatment related effects.
III. To evaluate 13C and 1H metabolic parameters to determine the association to time to progression and overall survival.
OUTLINE:
Participants are assigned to 3 cohorts based on disease status and non-investigational treatment plan. All participants enrolled in the study will receive at least 1 hyperpolarized pyruvate (13C) injection.
COHORT 1: Participants with newly diagnosed glioblastoma who will undergo standard of treatment with radiotherapy and temozolomide (TMZ). Magnetic resonance spectroscopic imaging (MRSI) imaging will occur at 2 time points: Before receiving non-investigational treatment with radiation and chemotherapy, and at the first post-radiation follow-up scan. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as a standard MR.
COHORT 2: Participants with recurrent, suspected GBM who will receive non-investigational surgical resection. MRSI imaging with hyperpolarized 13C pyruvate injection will occur at a single time point before surgery.
COHORT 3: Participants with recurrent suspected GBM who will undergo non-investigational standard treatment will have three MR examination time points. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as standard MR. The MR examinations will occur prior to initiating therapy (baseline), at approximately 7-14 days after initiation of therapy, and 6-8 weeks after the initiation of therapy.
Participants will be follow-up for up to 2 months after completion of non-investigational treatment, and for 7 days after final injection of hyperpolarized 13C.
- Being tested
- Hyperpolarized Pyruvate (13C), Magnetic Resonance Spectroscopic Imaging (MRSI)
- Keywords
- Imaging Study, Magnetic Resonance Spectroscopic Imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Pyruvate (13C)Drug
Also called HP-13C
Given at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution via intravenous injection over a period of about 1 minute once prior to each MRSI procedure.
Magnetic Resonance Spectroscopic Imaging (MRSI)Procedure or surgery
Also called MRSI
Undergo MRSI
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Newly Diagnosed Glioblastoma | Experimental | This arm is for participants with histologically proven newly diagnosed glioblastoma who will undergo non-investigational treatment with radiation therapy (RT) and temozolomide (TMZ).
Participants will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at two time points: before receiving standard treatment with RT/TMZ and at the first post-radiation follow-up scan (4-8 weeks later). Receives: Drug: Hyperpolarized Pyruvate (13C); Procedure: Magnetic Resonance Spectroscopic Imaging (MRSI) |
| Cohort 2: Recurrent Glioblastoma - Non-Investigational Surgical Resection | Experimental | This arm is for participants with histologically proven recurrent suspected glioblastoma who will receive surgical resection for the recurrence.
Participants will receive one injection of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at one time point: before surgery. Receives: Drug: Hyperpolarized Pyruvate (13C); Procedure: Magnetic Resonance Spectroscopic Imaging (MRSI) |
| Cohort 3: Recurrent Glioblastoma - Non-Investigational Treatment | Experimental | This arm is for participants with histologically proven recurrent suspected who will undergo standard treatment for the recurrence.
Participants will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at three time points: prior to treatment (baseline), approximately 7-14 days after the initiation of treatment, and 6-8 weeks after the initiation of treatment. Receives: Drug: Hyperpolarized Pyruvate (13C); Procedure: Magnetic Resonance Spectroscopic Imaging (MRSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events (AEs)
Participants will be monitored for the occurrence of treatment-emergent AEs assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 that occur during the course of study participation. AE monitoring occurs on each day of hyperpolarized 13C pyruvate administration until 7 days after administration. Serious adverse events occurring after 7 days after administration need only be reported if relationship to the investigational drug is suspected. The number of overall treatment emergent adverse events that occur will be reported for each cohort.
Measured: From Day 1 through study completion, up to 4 months
Number of Dose-Limiting Toxicities (DLTs)
A DLT for this protocol is defined as any event grade 3 or higher in severity assessed by the NCI CTCAE version 4.0 that is possibly, probably, or definitely attributable to the investigational drug, excluding laboratory abnormalities determined to be clinically insignificant. The number of DLTs for each cohort will be reported.
Measured: From Day 1 through study completion, up to 4 months
Mean Change in 13C Pyruvate-to-Lactate Conversion Rate (kPL) in Normal and Diseased Brain Tissues (Cohorts 1 and 3 ONLY)
The mean change in 13C kPL from baseline to the post-RT scan will be calculated for normal appearing brain and tumor(s) (lesions) for Cohorts 1 and 3. Cohort 2 was not assigned to receive a second scan for comparison.
Measured: Up to 8 weeks
Mean Changes in 13C Lactate/Pyruvate Ratio in Normal and Diseased Brain Tissues (Cohort 1 and 3 ONLY)
The mean changes in 13C lactate/pyruvate ratio from baseline to the post-RT scan will be compared in the normal appearing brain and tumor(s) (lesions) for participants in Cohorts 1 and 3. Cohort 2 was not assigned to receive a second scan for comparison.
Measured: Up to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start19 Nov 2019
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Chang
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Susan Chang, University of California, San Francisco
- Investigators
- Susan Chang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019002
- Sponsor's protocol ID
- 19105
- Other IDs
- 2P50CA097257, NCI-2019-07406
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2019
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Hyperpolarized and Proton Brain Metabolism in Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT04019002
- Acronym / sponsor ID
- 19105
- Keywords
- Imaging Study, Magnetic Resonance Spectroscopic Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Susan ChangUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment decisions and seeing how well various types of treatment work. The goal is to improve the way patient care is managed in the future.
If you chose to be in this study, you will be receiving novel magnetic resonance (MR) metabolic imaging with standard MR imaging. The research component includes an injection of an investigational agent, called hyperpolarized pyruvate 13C, to obtain dynamic metabolic imaging.
Detailed description
PRIMARY OBJECTIVES:
- To evaluation safety of hyperpolarized (HP) pyruvate (13C) injection for use in imaging lesions in participants with glioblastoma (GBM).
II. To evaluate metabolic changes in tumors and normal-appearing brain tissue in response to standard therapy.
EXPLORATORY OBJECTIVES:
- To evaluate changes in 13C parameters from baseline to the post-RT scan compared in the normal appearing brain, enhancing lesion, non-enhancing lesion and the choline-to-N -acetyl aspartate (NAA) index (CNI) lesion.
II. To evaluate 13C metabolic parameters from the recurrent lesions compared to those in the regions of treatment related effects.
III. To evaluate 13C and 1H metabolic parameters to determine the association to time to progression and overall survival.
OUTLINE:
Participants are assigned to 3 cohorts based on disease status and non-investigational treatment plan. All participants enrolled in the study will receive at least 1 hyperpolarized pyruvate (13C) injection.
COHORT 1: Participants with newly diagnosed glioblastoma who will undergo standard of treatment with radiotherapy and temozolomide (TMZ). Magnetic resonance spectroscopic imaging (MRSI) imaging will occur at 2 time points: Before receiving non-investigational treatment with radiation and chemotherapy, and at the first post-radiation follow-up scan. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as a standard MR.
COHORT 2: Participants with recurrent, suspected GBM who will receive non-investigational surgical resection. MRSI imaging with hyperpolarized 13C pyruvate injection will occur at a single time point before surgery.
COHORT 3: Participants with recurrent suspected GBM who will undergo non-investigational standard treatment will have three MR examination time points. Each time point includes a hyperpolarized 13C pyruvate injection for research imaging as well as standard MR. The MR examinations will occur prior to initiating therapy (baseline), at approximately 7-14 days after initiation of therapy, and 6-8 weeks after the initiation of therapy.
Participants will be follow-up for up to 2 months after completion of non-investigational treatment, and for 7 days after final injection of hyperpolarized 13C.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Newly Diagnosed Glioblastoma | Experimental | Drug: Hyperpolarized Pyruvate (13C), Procedure: Magnetic Resonance Spectroscopic Imaging (MRSI)This arm is for participants with histologically proven newly diagnosed glioblastoma who will undergo non-investigational treatment with radiation therapy (RT) and temozolomide (TMZ). Participants will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at two time points: before receiving standard treatment with RT/TMZ and at the first post-radiation follow-up scan (4-8 weeks later). |
| Cohort 2: Recurrent Glioblastoma - Non-Investigational Surgical Resection | Experimental | Drug: Hyperpolarized Pyruvate (13C), Procedure: Magnetic Resonance Spectroscopic Imaging (MRSI)This arm is for participants with histologically proven recurrent suspected glioblastoma who will receive surgical resection for the recurrence. Participants will receive one injection of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at one time point: before surgery. |
| Cohort 3: Recurrent Glioblastoma - Non-Investigational Treatment | Experimental | Drug: Hyperpolarized Pyruvate (13C), Procedure: Magnetic Resonance Spectroscopic Imaging (MRSI)This arm is for participants with histologically proven recurrent suspected who will undergo standard treatment for the recurrence. Participants will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at three time points: prior to treatment (baseline), approximately 7-14 days after the initiation of treatment, and 6-8 weeks after the initiation of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Cohort 1: Histologically proven newly diagnosed glioblastoma multiforme (GBM) who will undergo standard of treatment with radiation therapy (RT) and temozolomide (TMZ).
- Cohort 2: Histologically proven recurrent suspected GBM who will receive surgical resection for the recurrence.
- Cohort 3: Histologically proven recurrent suspected GBM who will undergo standard treatment for the recurrence.
- Patients must be >/= 18 years old and with a life expectancy > 16 weeks.
- Patients must have a Karnofsky performance status of ≥ 70.
Key exclusion criteria (1 listed)
- Subjects must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
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 |
|---|---|---|
| Hyperpolarized Pyruvate (13C)Also: HP-13CGiven at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution via intravenous injection over a period of about 1 minute once prior to each MRSI procedure. | Drug | Cohort 1: Newly Diagnosed Glioblastoma, Cohort 2: Recurrent Glioblastoma - Non-Investigational Surgical Resection, Cohort 3: Recurrent Glioblastoma - Non-Investigational Treatment |
| Magnetic Resonance Spectroscopic Imaging (MRSI)Also: MRSIUndergo MRSI | Procedure or surgery | Cohort 1: Newly Diagnosed Glioblastoma, Cohort 2: Recurrent Glioblastoma - Non-Investigational Surgical Resection, Cohort 3: Recurrent Glioblastoma - Non-Investigational Treatment |
Primary outcome
Number of Treatment Emergent Adverse Events (AEs)
Time frame: From Day 1 through study completion, up to 4 months
Participants will be monitored for the occurrence of treatment-emergent AEs assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 that occur during the course of study participation. AE monitoring occurs on each day of hyperpolarized 13C pyruvate administration until 7 days after administration. Serious adverse events occurring after 7 days after administration need only be reported if relationship to the investigational drug is suspected. The number of overall treatment emergent adverse events that occur will be reported for each cohort.
Number of Dose-Limiting Toxicities (DLTs)
Time frame: From Day 1 through study completion, up to 4 months
A DLT for this protocol is defined as any event grade 3 or higher in severity assessed by the NCI CTCAE version 4.0 that is possibly, probably, or definitely attributable to the investigational drug, excluding laboratory abnormalities determined to be clinically insignificant. The number of DLTs for each cohort will be reported.
Mean Change in 13C Pyruvate-to-Lactate Conversion Rate (kPL) in Normal and Diseased Brain Tissues (Cohorts 1 and 3 ONLY)
Time frame: Up to 8 weeks
The mean change in 13C kPL from baseline to the post-RT scan will be calculated for normal appearing brain and tumor(s) (lesions) for Cohorts 1 and 3. Cohort 2 was not assigned to receive a second scan for comparison.
Mean Changes in 13C Lactate/Pyruvate Ratio in Normal and Diseased Brain Tissues (Cohort 1 and 3 ONLY)
Time frame: Up to week 8
The mean changes in 13C lactate/pyruvate ratio from baseline to the post-RT scan will be compared in the normal appearing brain and tumor(s) (lesions) for participants in Cohorts 1 and 3. Cohort 2 was not assigned to receive a second scan for comparison.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Susan Chang, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperpolarized Pyruvate (13C) and Magnetic Resonance Spectroscopic Imaging (MRSI) in people with Glioblastoma and Recurrent Glioblastoma, run by Susan Chang 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 14 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Oct 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events (AEs) (time frame: From Day 1 through study completion, up to 4 months). The study lists 4 primary outcomes in all. 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 27 Oct 2026.