Recurrent World Health Organization (WHO) Grade II GliomaPhase 1NCT04540107
Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma
A Phase 1 study testing Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in people with Recurrent World Health Organization (WHO) Grade II Glioma and Recurrent WHO Grade III Glioma, run by Susan Chang at 1 site in United States.
Trial summary
This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma, WHO Grade II Glioma
- What is being tested?
- Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2017to 31 Jan 2027
- Phase
- 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
- For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
- For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
- Patients with a life expectancy > 12 weeks
- Patients must have a Karnofsky performance status of >= 60
- Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan.
- 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 participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
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- Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure
- Patients 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
- 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 they are in complete remission and have been off 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 will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures
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 California, San Francisco
San Francisco, California, 94143
Wendy Ma, 877-827-3222, cancertrials@ucsf.edu
Susan M. Chang, MD
About this study
Official title: Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans.
III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan.
OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility.
COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
- Conditions
- Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma, WHO Grade II Glioma, WHO Grade III Glioma
- Being tested
- Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopic Imaging
- Keywords
- Glioma, Hyperpolarized Pyruvate (13C)
- 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 C 13 PyruvateDrug
Also called Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS
Undergo MRSI
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT) | Experimental | Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist Receives: Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging |
| Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) | Experimental | Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Receives: Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events (AEs)
Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.
Measured: Up to 4 years
Peak lactate/pyruvate
The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.
Measured: Up to 4 years
Peak bicarbonate/pyruvate
The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.
Measured: Up to 4 years
Change in peak lactate/pyruvate between scans
The change in peak lactate/pyruvate between scans will be reported.
Measured: Baseline up to 4 years
Change in peak bicarbonate/pyruvate between scans
The change in peak bicarbonate/pyruvate between scans will be reported.
Measured: Baseline up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start11 Jan 2017
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent World Health Organization (WHO) Grade II GliomaStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susan Chang
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, Sigma-Aldrich, Phillips-Medisize, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Susan Chang, University of California, San Francisco
- Investigators
- Susan M Chang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540107
- Sponsor's protocol ID
- 161016
- Other IDs
- NCI-2019-08761, R01CA262630, P50CA097257-22
- Status last verified
- Apr 2026
- First submitted
- 31 Aug 2020
- Last updated
- 29 Apr 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
- ClinicalTrials.gov ID
- NCT04540107
- Acronym / sponsor ID
- 161016
- Conditions
- Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma, WHO Grade II Glioma, WHO Grade III Glioma
- Keywords
- Glioma, Hyperpolarized Pyruvate (13C)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Susan ChangUniversity, hospital or other
- Collaborators
- GE Healthcare, Sigma-Aldrich, Phillips-Medisize, National Cancer Institute (NCI)
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Sep 2020 (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 trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans.
III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan.
OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility.
COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT) | Experimental | Procedure: Magnetic Resonance Imaging, Procedure: Magnetic Resonance Spectroscopic ImagingPatients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist |
| Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) | Experimental | Drug: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Imaging, Procedure: Magnetic Resonance Spectroscopic ImagingPatients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
- For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
- Patients with a life expectancy > 12 weeks
- Patients must have a Karnofsky performance status of >= 60
- Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan.
Key exclusion criteria (1 listed)
- Subjects will be excluded from participating in this study if they are unable 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 Carbon C 13 PyruvateAlso: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)Given IV | Drug | Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MRI | Procedure or surgery | Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT), Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) |
| Magnetic Resonance Spectroscopic ImagingAlso: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRSUndergo MRSI | Procedure or surgery | Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT), Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) |
Primary outcome
Number of treatment-emergent adverse events (AEs)
Time frame: Up to 4 years
Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.
Peak lactate/pyruvate
Time frame: Up to 4 years
The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.
Peak bicarbonate/pyruvate
Time frame: Up to 4 years
The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.
Change in peak lactate/pyruvate between scans
Time frame: Baseline up to 4 years
The change in peak lactate/pyruvate between scans will be reported.
Change in peak bicarbonate/pyruvate between scans
Time frame: Baseline up to 4 years
The change in peak bicarbonate/pyruvate between scans will be reported.
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 29 Apr 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.
Susan M 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 Carbon C 13 Pyruvate, Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in people with Recurrent World Health Organization (WHO) Grade II Glioma and Recurrent WHO Grade III Glioma, 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 13 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: looking for participants now, as of the sponsor's last update on 29 Apr 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?
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 Wendy Ma (877-827-3222, cancertrials@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent adverse events (AEs) (time frame: Up to 4 years). The study lists 5 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 29 Apr 2026.