Assessing metabolic changes in brain tumors using advanced imaging techniques
Investigating Metabolic Characteristics of Intracranial Malignancy In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
This study is testing a new imaging technique to see how brain tumors change metabolism in patients with different types of brain cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03067467 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate metabolic alterations in patients with brain tumors by utilizing hyperpolarized carbon-13 magnetic resonance spectroscopic imaging (MRSI). The study will involve 25 participants diagnosed with various types of brain malignancies, including gliomas and meningiomas, who will undergo imaging sessions to assess metabolic phenotypes. Following the localization of the tumor, the study will measure the production of 13C-lactate and 13C-bicarbonate after administering hyperpolarized [1-13C]pyruvate. The findings from this pilot study are intended to provide preliminary data that could support larger clinical trials targeting brain tumor therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with a definitive diagnosis of brain tumors who have not yet received chemotherapy or radiation treatment.
Not a fit: Patients currently undergoing treatment with investigational agents or those who have received prior chemotherapy or radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of brain tumor metabolism and improve the efficacy of future anti-tumor therapies.
How similar studies have performed: Preliminary data from similar studies using hyperpolarized MRSI have shown promise, but this specific approach remains novel and untested in a larger context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jae Mo Park, PhD — UT Southwestern
- Study coordinator: Jeannie D Baxter, RN
- Email: jeannie.baxter@utsouthwestern.edu
- Phone: 214-645-2726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.