Monitoring 2-hydroxyglutarate levels in glioma patients

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 study focuses on understanding the biology of gliomas with IDH mutations by monitoring the accumulation of 2-hydroxyglutarate (2-HG) in the brain using advanced imaging techniques like magnetic resonance spectroscopy (MRS). Participants aged 18 and older with confirmed IDH1 or IDH2 mutations will undergo a series of evaluations, including medical history reviews, physical exams, and MRI scans. The goal is to detect disease progression and better understand the mechanisms behind higher-grade transformations in gliomas. This longitudinal observation aims to provide insights that could lead to improved diagnostic methods for gliomas.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:
* Participants must have histologically confirmed diffuse glioma with documented IDH1 or IDH2 mutation, confirmed by DNA sequencing the exception will be participants with brain lesions that are not safe for biopsy but clinically suspected to be diffuse glioma are allowed to enroll to the study to receive imaging study as part of the exploratory study
* Participants must have measurable disease.
* Age \>=18 years. Tumor biology of IDH-mutant gliomas are different in pediatric tumors. Therefore, children will be excluded from the study.
* Karnofsky performance \>= 70%.
* Participants must have documented normal kidney function as defined below:

Creatinine within normal institutional limits

OR

Creatinine clearance \>60 mL/min/1.73 m2 for Participants with creatinine levels above institutional normal (Measured or calculated creatinine clearance

-Participants must have adequate liver function as defined below:

total bilirubin \<=2x ULN (ULN 1.3 mg/dl) except for participants with Gilbert Syndrome

AST \< 3x ULN (ULN 34U/L)

ALT \< 3x ULN (ULN 55U/L)

-Ability of participants to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study, and that this is not a therapeutic clinical trial.

EXCLUSION CRITERIA:

* Participants who have contraindication to MRI examination, including, but not limited to, unable to receive gadolinium, medical instability, or any contraindication on MR Screening Form. Pregnant individuals are excluded because MRI contrast, planned to be used on this study, may be dangerous for the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to using of MRI contrast, breastfeeding should be discontinued for 72 hours following study imaging.
* Participants weighing \> 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
* Poorly controlled hypertension, with blood pressure \>150/90 mmHg.
* Congestive heart failure with New York Heart Association (NYHA) status \> 2.
* A medical history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG.
* Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma with an exacerbation within the past year.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Jing Wu, M.D. — National Cancer Institute (NCI)
• Study coordinator: NCI NOB Referral Group
• Email: ncinobreferrals@mail.nih.gov
• Phone: (866) 251-9686

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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.