Using advanced MRI techniques to evaluate lower grade gliomas

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 trial investigates the effectiveness of serial magnetic resonance imaging (MRI) and MR spectroscopic imaging (MRSI) in characterizing lower grade gliomas. The study aims to assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging for early detection of tumor progression and response to therapy. Participants will undergo MRI and MRSI scans, with some receiving hyperpolarized carbon C-13 pyruvate to enhance imaging results. The goal is to establish practical methods for evaluating and standardizing treatment in patients with brain tumors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
* For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
* Patients with a life expectancy \> 12 weeks
* Patients must have a Karnofsky performance status of \>= 60
* Patients must have adequate renal function (creatinine \< 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan.
* Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
* Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure
* Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment
* This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race
* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information
* Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation
* Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years
* Patients must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of hyperpolarized imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential

Exclusion Criteria:

* Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Susan M Chang, MD — University of California, San Francisco
• Study coordinator: Wendy Ma
• Email: cancertrials@ucsf.edu
• Phone: 877-827-3222

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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.