Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors

Study Overview
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Brief Summary
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This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized [1-13C] pyruvate) for magnetic resonance imaging (MRI). II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized [1-13C] pyruvate. OUTLINE: Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). After completion of study, participants are followed up periodically.

Official Title
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A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)

Conditions
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Malignant Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Central Nervous System

Intervention / Treatment
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* Other: Gadolinium
* Drug: Hyperpolarized Carbon C 13 Pyruvate
* Procedure: Magnetic Resonance Imaging
* Procedure: Magnetic Resonance Spectroscopic Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI Glomerular filtration rate (GFR) > 30 ml/min No allergy to gadolinium Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Refusal to have an IV placed for injection Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement Total bilirubin > 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN Gamma-glutamyltransferase (GGT) > 2.5 x ULN Pregnant or breast-feeding Cardiovascular risk, including: Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110 Congestive heart failure Myocardial infarction within the past year QT prolongation, defined as pretreatment corrected QT interval (QTc) > 440 msec in males or > 460 msec in females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br>Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes. | Drug: Hyperpolarized Carbon C 13 Pyruvate<br>* Given IV<br>* Other names: Hyperpolarized Pyruvate (13C);Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Magnetic Resonance Spectroscopic Imaging<br>* Undergo MRSI<br>* Other names: Proton Magnetic Resonance Spectroscopic Imaging;|
| Experimental: Known CNS Malignancy<br>Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). | Other: Gadolinium<br>* gadolinium enhanced MRI<br>* Other names: Gd;Drug: Hyperpolarized Carbon C 13 Pyruvate<br>* Given IV<br>* Other names: Hyperpolarized Pyruvate (13C);Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Magnetic Resonance Spectroscopic Imaging<br>* Undergo MRSI<br>* Other names: Proton Magnetic Resonance Spectroscopic Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 2 or Higher Toxicities | The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases) | 2 days (+/-2) after the scan |