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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

Inclusion Criteria:

• 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.

• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

Exclusion Criteria:

• 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 are taking thyroid hormone replacements, have a history of alcohol abuse or illicit drug use.

• Subjects who have contraindication to contrast enhanced MRI examination, including, but not limited to, medical instability, any contraindication on MR Screening Form, or an estimated glomerular filtration rate (eGFR) of ≤ 30 mL/min/1.73m2.

• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants