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

Trial ID or NCT#

NCT03565367

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
View All Criteria
Show Less

Investigator(s)

Reena Thomas, MD PhD
Reena Thomas, MD PhD
Neuro-oncologist
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Chirag Patel, MD, PhD

Contact us to find out if this trial is right for you.

Contact

Lewis Naya
650-725-0739

View on ClinicalTrials.gov