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

NCT03067467 | Recruiting FDA Drug

• 1 other identifier: STU 012017-070
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Screening (Baseline) and 1 day of Study Visit

Study Arms (1)

Brain Tumor Patients

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

Drug: Hyperpolarized 13C-Pyruvate; Drug: Gadolinium

Interventions

Hyperpolarized 13C-Pyruvate DRUG

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

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

Brain Tumor Patients

Gadolinium DRUG

Brain MRI performed with and without gadolinium-based contrast.

Also known as: Gadavist

Brain Tumor Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 Brain Tumor Patients

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.
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Interventions

Gadolinium; gadobutrol

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Jae Mo Park, PhD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeannie D Baxter, RN

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 1, 2017
• Study Start: June 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)