Brain Tumor AdultCancerBrain and nervesDrug
What this study is
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.
What's being tested
- Hyperpolarized 13C-Pyruvate
Intervention · DRUG
Hyperpolarized 13C-pyruvate IV bolus followed by brain MRSI.
- Gadolinium
Intervention · DRUG
Brain MRI performed with and without gadolinium-based contrast.
Study details
- Official title
- Investigating Metabolic Characteristics of Intracranial Malignancy in Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
- Sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Brain Tumor Adult
- Enrolling
- 25 people
- Starts
- 2019-06-01
- Est. completion
- 2026-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou 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.
- 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.
You can't join 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; 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUT Southwestern Medical Center
Dallas, Texas, United States
- Jae Mo Park, PhD · Contact
Recruiting
Study team
Sponsor
University of Texas Southwestern Medical Center
Study ID STU 012017-070
Principal investigator
Jae Mo Park, PhD
UT Southwestern
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.