Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment decisions and seeing how well various types of treatment work. The goal is to improve the way patient care is managed in the future.
If you chose to be in this study, you will be receiving novel magnetic resonance (MR) metabolic imaging with standard MR imaging. The research component includes an injection of an investigational agent, called hyperpolarized 13C pyruvate, to obtain dynamic metabolic imaging.
Eligibility Criteria
This trial is for adults with newly diagnosed or recurrent glioblastoma who are undergoing standard treatment. They must have a life expectancy of at least 16 weeks, good performance status, and adequate kidney function. Excluded are those with significant medical illnesses, recent heart issues, known HIV positivity, pregnancy or breastfeeding women, and anyone unable to follow the study procedures.Inclusion Criteria
My kidney function is good, with creatinine levels below 1.5 mg/dL.
My gender or race does not affect my eligibility for this study.
Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation
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Exclusion Criteria
Subjects unable to comply with study and/or follow-up procedures
Participant Groups
The trial tests a new type of metabolic imaging using hyperpolarized 13C pyruvate in combination with standard MR imaging. It aims to see if this can help make better treatment decisions for patients with glioblastoma by providing more detailed information about how treatments are working.
3Treatment groups
Experimental Treatment
Group I: Cohort 3: Recurrent- Standard TreatmentExperimental Treatment1 Intervention
This arm is for patients with histologically proven recurrent suspected glioblastoma who will undergo standard treatment for the recurrence.
Patients will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at three time points: prior to treatment (baseline), approximately 7-14 days after the initiation of treatment, and 6-8 weeks after the initiation of treatment.
Group II: Cohort 2: Recurrent- Standard Surgical ResectionExperimental Treatment1 Intervention
This arm is for patients with histologically proven recurrent suspected glioblastoma who will receive surgical resection for the recurrence.
Patients will receive one injection of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at one time point: before surgery.
Group III: Cohort 1: Newly Diagnosed- Standard TreatmentExperimental Treatment1 Intervention
This arm is for patients with histologically proven newly diagnosed glioblastoma who will undergo standard treatment with radiation therapy (RT) and temozolomide (TMZ).
Patients will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at two time points: before receiving standard treatment with RT/TMZ and at the first post-radiation follow-up scan (8 weeks later).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
Susan ChangLead Sponsor
National Cancer Institute (NCI)Collaborator