Assessing metabolic changes in brain tumors using advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.