NCT03739411 · Susan Chang
Hyperpolarized Imaging in Diagnosing Participants With Glioma
What this study is about
This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.
View original scientific description
This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.
Interventions
RADIATION
Hyperpolarized Carbon C 13 Pyruvate
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
RADIATION
Radiation Therapy
Undergo radiation therapy for cancer outside of this study.
DRUG
Chemotherapy
Undergo chemotherapy for cancer outside of this study.
Primary outcome measures
Incidence of adverse events
Time frame: Up to 24 months
Adverse events will be monitored from just before investigational medicinal product (IMP) administration until the end of study participation. Vital signs (blood pressure and heart rate only) will be recorded at baseline and 30 minutes post injection. For blood pressures and heart rate recorded after IMP administration, the following safety endpoints will be summarized for each part of the study: (1) The occurrence of changes from baseline, at each post-administration time point, greater than a pre-specified magnitude (20 mm Hg for systolic blood pressure, 10 mm Hg for diastolic blood pressure, 10 beats per minute for heart rate). (2) The occurrence of post-administration values outside the normal limits. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0
Peak lactate/pyruvate ratio in brain tissue
Time frame: Up to 24 months
The lactate/pyruvate ratio and/or glutamate/pyruvate will be compared in tumor versus normal appearing brain tissue. Comparisons will be made using a Wilcoxon signed rank test.
Peak lactate/pyruvate ratio in (13C) pyruvate scan
Time frame: Up to 4 months.
The lactate/pyruvate ratio and/or glutamate/pyruvate from baseline will be compared to the ratio on the post-radiation therapy (RT) repeat scan. Comparisons will be made using a Wilcoxon signed rank test.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For Participants in Cohort 1: Suspected or histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan. For Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment. To be included in the study all subjects must also meet the following criteria:
- Participants must be \> 18 years old and with a life expectancy \> 12 weeks.
- Participants must have a Karnofsky performance status of ≥ 60.
- Participants must have adequate renal function (creatinine \< 1.5 mg/dL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized 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 patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter 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 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 criteria
- 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. Patients must sign an authorization for the release of their protected health information.
- Participants may not be known to be human immunodeficiency virus (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 in complete remission and 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 child-bearing potential. Exclusion Criteria: 1\. Participants must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
Where
- San Francisco, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations