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MR Spectroscopy for Brain Tumor

N/A

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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...

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Arm 1Experimental Treatment1 Intervention

Monitoring of quantitative levels of 2-hydroxyglutarate (2-HG) via proton magnetic resonance spectroscopy (1H-MRS)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,666 Previous Clinical Trials

40,925,759 Total Patients Enrolled

Jing Wu, M.D.Principal InvestigatorNational Cancer Institute (NCI)

3 Previous Clinical Trials

219 Total Patients Enrolled

Media Library

3T MRI scanner Clinical Trial Eligibility Overview. Trial Name: NCT03952598 — N/A

Brain Tumor Research Study Groups: 1/Arm 1

Brain Tumor Clinical Trial 2023: 3T MRI scanner Highlights & Side Effects. Trial Name: NCT03952598 — N/A

3T MRI scanner 2023 Treatment Timeline for Medical Study. Trial Name: NCT03952598 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are being monitored in this research endeavor?

"Affirmative. The information posted to clinicaltrials.gov reveals that this experiment, first listed on October 16th 2019, is currently in search of participants. Approximately 270 patients are needed from 1 medical centre."

Answered by AI

Are individuals presently able to join in this clinical experimentation?

"Clinicaltrials.gov provides evidence that this trial is actively accepting patient enrolment, with the first post dated October 16th 2019 and last update on October 28th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy

2019. "Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03952598.

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