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

• Status: Suspended
• Trial end date: 2023-01-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel M. Spielman
• Collaborator: National Institutes of Health (NIH)

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