Overview
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.
Description
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for evaluating tumor burden and detecting early response to therapy in participants with glioma.
II. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C data from the brain, one hundred participants with evidence of residual disease from a prior MRI examination will have hyperpolarized metabolic imaging after receiving one or two injections of hyperpolarized 13 C pyruvate. For participants who are willing to receive two injections, the 2nd injection will be used to assess reproducibility, evaluate the performance of new acquisition methods, or compare metabolism between [1-13C]pyruvate and [213C]pyruvate.
III. To establish the time course of changes in hyperpolarized pyruvate and lactate peaks on a voxel by voxel basis from the dynamic hyperpolarized data after the injection(s) of hyperpolarized 13C pyruvate. Twenty participants will be studied before and after treatment with treatment in order to determine the time course of delivery of 13C pyruvate and the location of maximum pyruvate and lactate or glutamate signals in normal brain and in the region of T2 hyperintensity (T2L).
IV. To evaluate if participants who receive treatment with standard radiation and temozolomide exhibit a reduction in hyperpolarized 13C lactate/pyruvate or 13C glutamate/pyruvate at post-radiation follow-up compared to their baseline scan. A second group of twenty participants will be studied at the time determined from the prior group to provide the maximum contrast between lactate/pyruvate or glutamate/pyruvate in the lesion versus normal brain.
OUTLINE: Participants are assigned to 1 of 2 cohorts.
COHORT I: Participants receive one or two hyperpolarized carbon C 13 pyruvate injections intravenously (IV) and undergo MRI.
COHORT II: Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of treatment.
After completion of study treatment, participants are followed for up to 24 months.
Eligibility
Inclusion Criteria:
For Participants in Cohort 1: 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:
1. Participants must be > 18 years old and with a life expectancy > 12 weeks.
2. Participants must have a Karnofsky performance status of ≥ 60.
3. 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.
4. 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.
5. Participants must not have New York Heart Association (NYHA) Grade II or greater
congestive heart failure
6. Participants must not have a history of myocardial infarction or unstable angina
within 12 months prior to study enrollment.
7. 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.
8. 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.
9. Participants may not be known to be human immunodeficiency virus (HIV)-positive. HIV
testing is not required for study participation.
10. 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.
11. 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.