NCT03067467 Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
| NCT ID | NCT03067467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Brain Tumor Adult |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2019-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2019-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jae Mo Park, PhD
PRINCIPAL INVESTIGATOR
UT Southwestern
Frequently Asked Questions
Who can join the NCT03067467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Brain Tumor Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03067467 currently recruiting?
Yes, NCT03067467 is actively recruiting participants. Contact the research team at jeannie.baxter@utsouthwestern.edu for enrollment information.
Where is the NCT03067467 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT03067467 clinical trial?
NCT03067467 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Jae Mo Park, PhD at UT Southwestern. The trial plans to enroll 25 participants.