Palo Alto, California 94304

  • Metastatic Malignant Neoplasm in the Central Nervous System

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03565367


Primary Contact:

Principal Investigator
Lawrence Recht
Stanford University


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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