RecruitingNCT03067467

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

Investigating Metabolic Characteristics of Intracranial Malignancy In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

Sponsor

University of Texas Southwestern Medical Center

Enrollment

25 participants

Start Date

Jun 1, 2019

Study Type

OBSERVATIONAL

Conditions

Brain Tumor Adult

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

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.

Exclusion Criteria21

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