Brain Tumor Adult Clinical Trial
— HPCIMOfficial title:
Investigating Metabolic Characteristics of Intracranial Malignancy In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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