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RecruitingNCT03067467HPCIMUpdated Mar 10, 2026

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

An observational study in Brain Tumor Adult, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by University of Texas Southwestern Medical Center · Observational

From the registry’s dates

  • Started Jun 2019; still recruiting 7 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

The aim of this pilot study is to test the hypothesis that patients with brain malignancy present altered [1-13C]lactate and 13C-bicarbonate production from infused hyperpolarized [1-13C]pyruvate in tumor as compared to in normal-appearing brain regions. To achieve this aim investigators will assess metabolic phenotype in cancer patients with brain tumors (n = 20). Total target enrollment will be set at 25 subjects to account for attrition and screening failures.

During each imaging session, following localization of the tumor in brain, tissue characteristics and morphological changes will be evaluated with 1H MRI. Then, cerebral metabolism will be assessed utilizing 13C MRSI after an intravenous injection with hyperpolarized [1-13C]pyruvate. Finally, contrast-enhanced 1H MRI will be acquired. The study agent, hyperpolarized [1-13C]pyruvate, will be administered under a Food and Drug Administration (FDA) Investigational New Drug (IND), which was approved on 1/3/2017 (IND# 133229).

Preliminary data in human are essential to secure larger scale funding required for clinical studies. The investigators believe the ability to measure such metabolic shifts in vivo could have major significance in assessing the efficacy of multiple anti-tumor therapies currently under development that target reversing the Warburg effect as a means of controlling tumor growth. Brain tumor applications at the Advanced Imaging Research Center, Harold C. Simmons Comprehensive Cancer Center and the Neuro-Oncology Program of the Development of Neurological Surgery at the UT Southwestern Medical Center offer today a unique opportunity to lead globally the translational scientific efforts in this field.

02

Conditions studied

  • Brain Tumor Adult
03

In context

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

20 Brain Tumor Patients

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • Brain Tumor Patients

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

    Drug: Hyperpolarized 13C-Pyruvate · Drug: Gadolinium

Interventions

  • DrugHyperpolarized 13C-Pyruvate

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

    Also known as: HP [1-13C]pyruvate

  • DrugGadolinium

    Brain MRI performed with and without gadolinium-based contrast.

    Also known as: Gadavist

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
    • Jae Mo Park, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03067467
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Jae Mo Park (Assistant Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Mar 1, 2017
Start date
Jun 1, 2019
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 10, 2026

Study contacts

Jeannie D Baxter, RN
Contact
jeannie.baxter@utsouthwestern.edu
214-645-2726
Jae Mo Park, PhD
principal investigator · UT Southwestern

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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