About this trial
This is a non-randomized, purely observational, feasibility study to detect metabolic changes in patients with brain malignancy using a novel hyperpolarized \[1-13C\]pyruvate MRSI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Definitive diagnosis of brain tumors by imaging which demonstrates all kinds of brain malignancy, including glioma, meningioma, and brain metastases prior to any chemotherapy or radiation treatment.
18-70 years of age
Ability to understand and the willingness to sign a written informed consent.
All races and ethnicities will be included; subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
Disqualifiers
Subjects who are receiving any other investigational agents.
Previous or current treatment by radiation or chemotherapy.
Concurrent illness including, but not limited to, ongoing or active infection, uncontrolled chronic diseases such as hypertension, lung disease, liver disease, kidney disease, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
Subjects who have a history of alcohol abuse or illicit drug use.
Trial population
20 Brain Tumor Patients
Trial design
Case-control
Prospective
Treatments tested in this trial
Hyperpolarized 13C-Pyruvate
DrugHyperpolarized 13C-pyruvate IV bolus followed by brain MRSI.
Gadolinium
DrugBrain MRI performed with and without gadolinium-based contrast.
Treatment groups
Trial outcomes
Primary outcomes
13C-pyruvate Metabolic Product Ratio
Measurement of the ratio of metabolic products, \[1-13C\]lactate and 13C-bicarbonate, from hyperpolarized \[1-13C\]pyruvate will be used as an index of metabolic balance between glycolytic pathway and mitochondrial oxidative phosphorylation.
Sponsors and contacts
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