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

Daniel M. Spielman9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes