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

Not Recruiting

Trial ID: NCT03565367

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.

Official Title

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

Stanford Investigator(s)

Reena Thomas, MD PhD
Reena Thomas, MD PhD

Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery

Eligibility


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

Intervention(s):

other: Gadolinium

drug: Hyperpolarized Carbon C 13 Pyruvate

procedure: Magnetic Resonance Imaging

procedure: Magnetic Resonance Spectroscopic Imaging

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lewis Naya
650-725-0739

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