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Observational Study of Brain Tumors Using Hyperpolarized Carbon-13 MRSI

This observational study is looking at the metabolic characteristics of adult brain tumors. Researchers are using a special imaging technique called Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI) after giving you an IV injection of Hyperpolarized 13C-Pyruvate. You will also have standard brain MRI scans, some with a contrast agent called Gadolinium. The goal is to see if brain tumors show different metabolic activity compared to healthy brain tissue. This study is for adults aged 18 to 70 who have a confirmed brain tumor diagnosis and have not yet received chemotherapy or radiation. The study aims to enroll 25 participants to understand these metabolic changes.

Study design
This is an observational study, meaning researchers will be watching and collecting information without giving a specific treatment. It aims to enroll 25 participants.
What's involved
You will undergo an MRI scan with and without Gadolinium, and receive an IV injection of Hyperpolarized 13C-Pyruvate followed by a special MRSI scan. These procedures will occur at screening and one day of a study visit.
Compensation
Not stated in the trial record.
Follow-up
Your metabolic product ratio will be measured at screening (baseline) and one day of a study visit.

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NCT03067467

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

Recruiting
Not specifiedAges 18–70Observational
University of Texas Southwestern Medical Center
~25 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:Hyperpolarized 13C-PyruvateGadolinium

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
13C-pyruvate Metabolic Product Ratio
Measured over Screening (Baseline) and 1 day of Study Visit

Conditions

Brain Tumor Adult

Explore related trials

Brain Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jae Mo Park, PhD · PRINCIPAL_INVESTIGATOR · UT Southwestern

Who to contact

Jeannie D Baxter, RN
[email protected]
214-645-2726
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • 13C-pyruvate Metabolic Product RatioScreening (Baseline) and 1 day of Study Visit

    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.