NCT04540107 · Susan Chang
Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Hyperpolarized Carbon C 13 Pyruvate
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Primary outcome measures
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.
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 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 criteria
- 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 Criteria:
- Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures
Where
- San Francisco, California
Collaborators
GE Healthcare, Sigma-Aldrich, Phillips-Medisize, 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 Apr 29, 2026 · Source of record for eligibility and locations