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MR Imaging and MR Spectroscopic Imaging for Lower Grade Glioma

This study is looking at how well special MRI scans, called Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI), can help doctors understand and track lower grade glioma (a type of brain tumor). You would receive a drug called Hyperpolarized Carbon C 13 Pyruvate intravenously (into your vein) and undergo these special MRI scans. Researchers want to see if changes in certain chemicals detected by these scans can show if your tumor is growing or responding to treatment. The study aims to enroll 300 participants. To join, you must have a lower grade glioma that has been confirmed by a biopsy, be at least 18 years old, and have a life expectancy of more than 12 weeks. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 300 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo MRI and MRSI scans. For Cohort 2, you would also receive Hyperpolarized Carbon C 13 Pyruvate intravenously. The study measures outcomes for up to 4 years.
Compensation
Not stated in the trial record.
Follow-up
The study will track certain outcomes, like adverse events and chemical levels, for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04540107

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Susan Chang
~300 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Hyperpolarized Carbon C 13 PyruvateMagnetic Resonance ImagingMagnetic Resonance Spectroscopic Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatment-emergent adverse events (AEs)
Measured over Up to 4 years
+4 more outcomes measured

Conditions

Recurrent World Health Organization (WHO) Grade II Glioma
Recurrent WHO Grade III Glioma
WHO Grade II Glioma
WHO Grade III Glioma

Explore related trials

Glioma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Susan M Chang, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Wendy Ma
[email protected]
877-827-3222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

Exclusion

Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

What this trial measures

  • Number of treatment-emergent adverse events (AEs)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/pyruvateUp to 4 years

    The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.

  • Peak bicarbonate/pyruvateUp to 4 years

    The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.

  • Change in peak lactate/pyruvate between scansBaseline up to 4 years

    The change in peak lactate/pyruvate between scans will be reported.

  • Change in peak bicarbonate/pyruvate between scansBaseline up to 4 years

    The change in peak bicarbonate/pyruvate between scans will be reported.