Hyperpolarized Imaging in Diagnosing Participants With Glioma

Susan Chang

Status and phase: Enrolling; Phase 1

Conditions: Glioma

Treatments: Radiation: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Drug: Chemotherapy; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03739411

R01CA273028 (U.S. NIH Grant/Contract)

R01CA109767 (U.S. NIH Grant/Contract)

2P50CA097257 (U.S. NIH Grant/Contract)

13106

NCI-2018-00939 (Registry Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Cohort I (Hyperpolarized C13, MRI)

Experimental group

Description:

Participants receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRI. The second hyperpolarized 13 C injection/imaging will be started approximately 15 to 60 minutes after the first injection for those who are willing to receive two 13 C injections

Treatment:

Procedure: Magnetic Resonance Imaging

Radiation: Hyperpolarized Carbon C 13 Pyruvate

Cohort II (Hyperpolarized C13, MRI)

Experimental group

Description:

Participants receive hyperpolarized carbon C 13 pyruvate IV and undergo MRI before treatment and 4 weeks after completion of cancer therapy given outside of this study.

Treatment:

Drug: Chemotherapy

Radiation: Radiation Therapy

Procedure: Magnetic Resonance Imaging

Radiation: Hyperpolarized Carbon C 13 Pyruvate