Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Texas Southwestern Medical Center

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Hyperpolarized 13C-Pyruvate

    Drug

    Hyperpolarized 13C-pyruvate IV bolus followed by brain MRSI.

  • Gadolinium

    Drug

    Brain MRI performed with and without gadolinium-based contrast.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Brain Tumor Patients2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Screening (Baseline) and 1 day of Study Visit

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.