Hyperpolarized Carbon-13 MRSI for the Investigation of Metabolic Characteristics of Brain Tumors
This clinical trial evaluates hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging (MRSI) for the investigation of metabolic characteristics of brain tumors. Cancer is a disease that can alter tissue metabolism. Information from this study may help doctors predict a patient's response to treatment and may help develop new treatments for brain cancer.
Inclusion Criteria
- BRAIN TUMOR PATIENTS: 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 through 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
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 who have contraindication to contrast enhanced MRI examination; Contraindications to MRI examination include: * Medically unstable ** Heart failure ** Severe left ventricular outflow tract (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: ** Estimated glomerular filtration rate (eGFR) =< 30 mL/min/1.73m^2 ** Sickle cell disease ** Hemolytic anemia
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Additional locations may be listed on ClinicalTrials.gov for NCT03067467.
Locations matching your search criteria
United States
Texas
Dallas
PRIMARY OBJECTIVE:
I. To determine whether the ratio of metabolic products, [1-13C]lactate and 13C-bicarbonate, in the tumor and the normal-appearing brain regions from hyperpolarized carbon C 13 pyruvate (hyperpolarized [1-13C]pyruvate) will be used as an index of metabolic balance between glycolytic pathway and mitochondrial oxidative phosphorylation in patients with brain tumors.
SECONDARY OBJECTIVES:
I. Spatial heterogeneity of lactate and pyruvate maps will be assessed by voxel-by-voxel analysis and compared with magnetic resonance spectroscopic imaging (1H MRI).
II. If available, existing fludeoxyglucose F-18 (FDG)-positron emission tomography ([18F]FDG-PET) data from the recruited patients will be compared with the 13C metabolite maps.
III. Carbon-13 (C13) nuclear magnetic resonance spectroscopy (13C NMR spectra) from tumor tissue removed at the time of surgical resection will be generated and the active metabolic pathways in each tumor will be identified, determining its metabolic phenotype.
OUTLINE:
Participants receive hyperpolarized [1-13C]pyruvate intravenously (IV) and undergo 1H MRI. Participants may also receive gadolinium IV during 1H MRI. Participants may then receive 1,2-Carbon C 13-labeled glucose and carbon C 13 acetate IV prior to standard of care craniotomy.
After completion of study intervention, patients are followed up within 24 hours.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorJae Mo Park
- Primary IDSCCC-07317; STU 012017-070
- Secondary IDsNCI-2021-02177
- ClinicalTrials.gov IDNCT03067467