Clinical trial NCT03739411: Hyperpolarized Imaging in Diagnosing Participants With Glioma
Official title: Pilot Study of Safety and Feasibility of Acquiring Hyperpolarized Imaging in Patients With Gliomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Glioma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-11-13
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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 criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 24 months
measure: Peak lactate/pyruvate ratio in brain tissue
timeFrame: Up to 24 months
measure: Peak lactate/pyruvate ratio in (13C) pyruvate scan
timeFrame: Up to 4 months.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Susan Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Autry AW, Gordon JW, Chen HY, LaFontaine M, Bok R, Van Criekinge M, Slater JB, Carvajal L, Villanueva-Meyer JE, Chang SM, Clarke JL, Lupo JM, Xu D, Larson PEZ, Vigneron DB, Li Y. Characterization of serial hyperpolarized 13C metabolic imaging in patients with glioma. Neuroimage Clin. 2020;27:102323. doi: 10.1016/j.nicl.2020.102323. Epub 2020 Jun 24.