Recruiting

Brain Tumors

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT03067467

Conditions

Brain Tumor Adult

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 13C-Pyruvate

Gadolinium

Study Details

Brief 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.

Conditions

Brain Tumor Adult

Study ID

NCT03067467

Start date

Jun 1, 2019

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Brain Tumor Patients

Brain Tumor patients will receive a bolus of Hyperpolarized 13C-pyruvate during MRSI.

Interventions

Hyperpolarized 13C-Pyruvate

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

Gadolinium

Brain MRI performed with and without gadolinium-based contrast.

Primary outcome measure

  • 13C-pyruvate Metabolic Product Ratio [ Time Frame: Screening (Baseline) and 1 day of Study Visit ]

Central Contacts and Locations

Central contacts

Jeannie D Baxter, RN

214-645-2726jeannie.baxter@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-03-10.