Adult Gliomas, MixedEarly Phase 1NCT05851378
Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma
A Early Phase 1 study testing Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG) and Magnetic Resonance Image (MRI) in people with Adult Gliomas, Mixed, run by Robert Bok, MD, PhD at 1 site in United States.
Trial summary
This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Gliomas, Mixed
- What is being tested?
- Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG) and Magnetic Resonance Image (MRI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 31 Jan 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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. Participants must be > 18 years old who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion > 1 cubic centimetre (cc))
- Cohort 1: Participants with IDH mutant glioma who may or may not have received prior treatment
- Cohort 2: Participants with recurrent IDH mutant glioma before receiving surgical resection,
- All the subjects must have prior MR scans available for review to assess the location and size of residual/recurrent tumor and do not have contraindication for magnetic resonance (MR) examinations. To be included in the study all subjects must also meet the following criteria:
- Participants must have a life expectancy > 8 weeks.
- Participants must have a Karnofsky performance status of > 70.
Show all 15Show fewer
- Participants must have adequate renal function (creatinine < 1.5 mg/dL). This test must be performed within 60 days prior to the HP 13C Imaging scan.
- Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the participant's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
- Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Participants must not have 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.
- Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Participants must sign an authorization for the release of their protected health information.
- Participants may not be known to be HIV-positive. HIV testing is not required for study participation.
- Participants must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years.
- Participants 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 childbearing potential.
Who cannot join
- 1. Participants are excluded from participating in this study if they are not able to comply with study 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: Hyperpolarized Carbon-13 Alpha-ketoglutarate Metabolic Imaging in IDH Mutant Glioma
This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.
Read the detailed description
PRIMARY OBJECTIVES:
- To define the most appropriate imaging parameters for obtaining hyperpolarized 13C-aKG from participants with IDH mutant glioma.
II. To assess the safety and feasibility of hyperpolarized 13C-aKG magnetic resonance (MR) metabolic imaging as a new and unique tool for evaluating tumor burden in participants with IDH mutant glioma.
OUTLINE:
Participants will be assigned to one of 2 cohorts:
COHORT 1: Participants with IDH mutant glioma for sequence development.
COHORT 2: Participants with recurrent IDH mutant glioma before receiving surgical resection.
This imaging study will involve one MR scan with the administration of HP 13C-aKG and will receive a follow-up phone call within 1-7 days post-study to assess for late adverse events.
- Conditions
- Adult Gliomas, Mixed
- Being tested
- Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG), Magnetic Resonance Image (MRI)
- Keywords
- Isocitrate Dehydrogenase Mutation
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG)Drug
Also called Hyperpolarized C13-aKG, HP C13-aKG
Given intravenously at time of imaging
Magnetic Resonance Image (MRI)Procedure or surgery
Also called MRI, MRI scan
Magnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG) | Experimental | Cohort 1 will be comprised of 10 participants with Isocitrate dehydrogenase (IDH) mutant glioma who may or may not have received prior treatment for optimizing imaging protocol. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan. |
| Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG) | Experimental | Cohort 2 will be comprised 30 participants with recurrent IDH mutant glioma before receiving surgical resection. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean signal to noise ratio of HP 13C-aKG
Signal-to-noise ratio (SNR) of HP 13C-aKG will be calculated voxel-by-voxel, and within each region of interest (ROI). The parameters considered will be the mean SNR, within these ROIs. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast.
Measured: Day of imaging (1 day)
Mean signal to noise ratio of oncometabolite 2-hydroxyglutarate (2-HG)
Signal-to-noise ratio (SNR) of HP 13C akG 2HG will be calculated voxel-by-voxel, and within each ROI. The parameters considered will be the mean SNR, the number of voxels with SNR 2HG within the normal brain > 3.0, the number of voxels with SNR 2HG within the lesion > 3.0. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast. (2HG production only in the IDH mutant tumors).
Measured: Day of imaging (1 day)
Mean signal to noise ratio of of glutamate
Signal-to-noise ratio (SNR) of 13C aKG glutamate will be calculated voxel-by-voxel, and within each region of interest. The parameters considered will be the number of voxels with SNR glutamate within the normal brain > 3.0, the number of voxels with SNR glutamate within the lesion > 3.0, Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (reduced glutamate within the lesion compared to the normal brain).
Measured: Day of imaging (1 day)
Median signal to noise ratio of 2HG to aKG
Metabolite ratios (2HG/aKG) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors within the lesion compared to the normal brain).
Measured: Day of imaging (1 day)
Mean signal to noise ratio of 2HG to glutamate
Metabolite ratios (2HG/glutamate) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors and reduced glutamate within the lesion compared to the normal brain).
Measured: Day of imaging (1 day)
Proportion of participants who reported treatment-emergent adverse events
Occurrence of clinically significant changes in safety variables, including injection site, as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.
Measured: Day of imaging (1 day)
Comparison of HP 13C 2HG/aKG ratio with surgical results (Cohort 2)
In Cohort 2, the ratio of 13C (2HG/aKG will be compared within normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Measured: Day of imaging (1 day)
Comparison of HP 13C 2HG/glutamate ratio with surgical results (Cohort 2)
In Cohort 2, the ratio of 13C 2HG/glutamate will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Measured: Day of imaging (1 day)
Comparison of HP 13C glutamate/aKG ratio with surgical results (Cohort 2)
In Cohort 2, the ratio of 13C glutamate/aKG will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Measured: Day of imaging (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start11 Apr 2023
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Gliomas, MixedStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bok, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Robert Bok, MD, PhD, University of California, San Francisco
- Investigators
- Susan Chang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851378
- Sponsor's protocol ID
- 22925
- Other IDs
- NCI-2023-03744, 5P01CA118816-12, 2P50CA097257
- Status last verified
- Aug 2026
- First submitted
- 1 May 2023
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Carbon-13 Alpha-ketoglutarate Metabolic Imaging in IDH Mutant Glioma
- ClinicalTrials.gov ID
- NCT05851378
- Acronym / sponsor ID
- 22925
- Conditions
- Adult Gliomas, Mixed
- Keywords
- Isocitrate Dehydrogenase Mutation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Robert Bok, MD, PhDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 9 May 2023 (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 study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.
Detailed description
PRIMARY OBJECTIVES:
- To define the most appropriate imaging parameters for obtaining hyperpolarized 13C-aKG from participants with IDH mutant glioma.
II. To assess the safety and feasibility of hyperpolarized 13C-aKG magnetic resonance (MR) metabolic imaging as a new and unique tool for evaluating tumor burden in participants with IDH mutant glioma.
OUTLINE:
Participants will be assigned to one of 2 cohorts:
COHORT 1: Participants with IDH mutant glioma for sequence development.
COHORT 2: Participants with recurrent IDH mutant glioma before receiving surgical resection.
This imaging study will involve one MR scan with the administration of HP 13C-aKG and will receive a follow-up phone call within 1-7 days post-study to assess for late adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG) | Experimental | –Cohort 1 will be comprised of 10 participants with Isocitrate dehydrogenase (IDH) mutant glioma who may or may not have received prior treatment for optimizing imaging protocol. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan. |
| Cohort 2: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG) | Experimental | –Cohort 2 will be comprised 30 participants with recurrent IDH mutant glioma before receiving surgical resection. Participants will be injected with 0.67ml/kg actual body weight of 100 millimolar (mM) of α-KG solution and have a single imaging scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Participants must be > 18 years old who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion > 1 cubic centimetre (cc))
- Cohort 1: Participants with IDH mutant glioma who may or may not have received prior treatment
- Cohort 2: Participants with recurrent IDH mutant glioma before receiving surgical resection,
- All the subjects must have prior MR scans available for review to assess the location and size of residual/recurrent tumor and do not have contraindication for magnetic resonance (MR) examinations. To be included in the study all subjects must also meet the following criteria:
- Participants must have a life expectancy > 8 weeks.
Key exclusion criteria (1 listed)
- 1. Participants are excluded from participating in this study if they are not able to comply with study 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 Carbon 13 Alpha-ketoglutarate (HP C13-aKG)Also: Hyperpolarized C13-aKG, HP C13-aKGGiven intravenously at time of imaging | Drug | – |
| Magnetic Resonance Image (MRI)Also: MRI, MRI scanMagnetic resonance imaging is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body | Procedure or surgery | – |
Primary outcome
Mean signal to noise ratio of HP 13C-aKG
Time frame: Day of imaging (1 day)
Signal-to-noise ratio (SNR) of HP 13C-aKG will be calculated voxel-by-voxel, and within each region of interest (ROI). The parameters considered will be the mean SNR, within these ROIs. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast.
Mean signal to noise ratio of oncometabolite 2-hydroxyglutarate (2-HG)
Time frame: Day of imaging (1 day)
Signal-to-noise ratio (SNR) of HP 13C akG 2HG will be calculated voxel-by-voxel, and within each ROI. The parameters considered will be the mean SNR, the number of voxels with SNR 2HG within the normal brain > 3.0, the number of voxels with SNR 2HG within the lesion > 3.0. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast. (2HG production only in the IDH mutant tumors).
Mean signal to noise ratio of of glutamate
Time frame: Day of imaging (1 day)
Signal-to-noise ratio (SNR) of 13C aKG glutamate will be calculated voxel-by-voxel, and within each region of interest. The parameters considered will be the number of voxels with SNR glutamate within the normal brain > 3.0, the number of voxels with SNR glutamate within the lesion > 3.0, Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (reduced glutamate within the lesion compared to the normal brain).
Median signal to noise ratio of 2HG to aKG
Time frame: Day of imaging (1 day)
Metabolite ratios (2HG/aKG) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors within the lesion compared to the normal brain).
Mean signal to noise ratio of 2HG to glutamate
Time frame: Day of imaging (1 day)
Metabolite ratios (2HG/glutamate) will be calculated voxel-by-voxel, and within each ROI. Median, maximum, and sum of ratios will be reported. Acquisition parameters will be optimized (such as spatial resolution) to have the highest metabolite SNR and metabolite contrast (2HG production only in the IDH mutant tumors and reduced glutamate within the lesion compared to the normal brain).
Proportion of participants who reported treatment-emergent adverse events
Time frame: Day of imaging (1 day)
Occurrence of clinically significant changes in safety variables, including injection site, as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.
Comparison of HP 13C 2HG/aKG ratio with surgical results (Cohort 2)
Time frame: Day of imaging (1 day)
In Cohort 2, the ratio of 13C (2HG/aKG will be compared within normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Comparison of HP 13C 2HG/glutamate ratio with surgical results (Cohort 2)
Time frame: Day of imaging (1 day)
In Cohort 2, the ratio of 13C 2HG/glutamate will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Comparison of HP 13C glutamate/aKG ratio with surgical results (Cohort 2)
Time frame: Day of imaging (1 day)
In Cohort 2, the ratio of 13C glutamate/aKG will be compared within a normal appearing brain versus a brain with visible lesions using a two-sided paired t-test or Wilcoxon signed rank test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Adult Gliomas, Mixed
RecruitingPhase 1
GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults
Medulloblastoma, Central Nervous System Embryonal Tumor
Active, not recruitingPhase 3
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Brain and Central Nervous System Tumors, Neurotoxicity
Active, not recruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
Pediatric Solid Tumor, Pediatric Lymphoma
RecruitingPhase 1
B7-H3.CD28Z.CART in CNS Neoplasms
Central Nervous System Neoplasms, Brain Tumor
Active, not recruitingPhase 1
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma
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 Early Phase 1 study testing Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG) and Magnetic Resonance Image (MRI) in people with Adult Gliomas, Mixed, run by Robert Bok, MD, PhD 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 15 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: finished, as of the sponsor's last update on 12 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean signal to noise ratio of HP 13C-aKG (time frame: Day of imaging (1 day)). The study lists 9 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 12 Aug 2026.