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MR Spectroscopy for Brain Tumor

Phase 2

Recruiting

Led By Jing Wu, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have normal kidney function as defined below: creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients withcreatinine levels above institutional normal (Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl)).

Karnofsky performance greater than or equal to 60%.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how 2-HG builds up in the brain in people with gliomas that have mutations in the IDH1 or IDH2 genes.

Who is the study for?

This trial is for adults with gliomas (a type of brain cancer) that have specific mutations called IDH1 or IDH2. Participants must be over 18, able to perform daily activities at a reasonable level, and have normal kidney function. Pregnant women and individuals with conditions that could affect the study are excluded.

What is being tested?

The study uses advanced MRI scans to monitor levels of a substance called 2-HG in the brains of patients with these gene mutations. The goal is to understand how this buildup relates to tumor aggressiveness and help design better diagnostic tests.

What are the potential side effects?

There may be side effects related to the MRI contrast agent used during scans, such as allergic reactions. Also, discomfort from lying still during scanning and potential risks associated with intravenous injections can occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal, based on creatinine levels or clearance.

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I can care for myself but may need occasional help.

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My glioma has an IDH1 or IDH2 mutation confirmed by a DNA test.

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I am 18 years or older.

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My brain tumor is classified as grade II, III, or IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To monitor the quantitative levels of 2-hydroxyglutarate (2-HG) longitudinally in patients with IDH mutant gliomas via proton magnetic resonance spectroscopy (1H-MRS)

Secondary study objectives

Determine the utility of 2-HG detection by 1H-MRS to predict higher-grade transformation (HT) and hypermutator phenotype (HMP) by correlating the 2-HG level with pathological diagnosis and tumor mutational load of the tumor tissue at time of rec...