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

Recruiting now

Conditions studied: Brain Tumor Adult

In brief

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.

Key facts

Study ID

NCT03067467

Run by

University of Texas Southwestern Medical Center

People needed

25

Starts

2019-06-01

Expected to finish

2026-12-31

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• Subjects who have contraindication to contrast enhanced MRI examination
• Contraindications to MRI examination include:
• Medically unstable
• Heart failure
• Severe LVOT outflow obstruction
• Unstable angina
• Child bearing
• Lactating
• Any contraindication per MRI Screening Form including
• Implants contraindicated at 3T, pacemakers
• Implantable Cardioverter Defibrillator (ICD)
• Claustrophobia
• Since each subject may be receiving a gadolinium-based contrast agent intravenously:
• eGFR ≤ 30 mL/min/1.73m2
• Sickle cell disease
• Hemolytic anemia

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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