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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-C-0096

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Pregnant Women;
Children

Keywords

Imaging;
Higher-Grade Transformation;
Biomarker for Cancer;
High Grade Gliomas

Recruitment Keyword(s)

None

Condition(s)

Glioma;
Gliomas;
High Grade Glioma;
Malignant Glioma;
Low Grade Glioma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: 3T MRI scanner

Supporting Site

National Cancer Institute

Background:

Glioma is a type of brain cancer. Some of these tumors have gene mutations. These mutations can cause a substance called 2-HG to build up in the brain. This makes the tumors more aggressive. Researchers want to better understand 2-HG buildup in the brain. They hope this can help them design better ways to test for gliomas.

Objective:

To monitor the level of 2-HG in the brains of people with gliomas that have mutations in the IDH1 or IDH2 genes.

Eligibility:

People ages 18 and older with gliomas with mutations in the IDH1 or IDH2 genes

Design:

Participants will be screened with:

Medical and cancer history

Physical exam

Reviews of their symptoms and ability to perform normal activities

Blood and urine tests

MRI scan

Samples of their tumor from a past surgery

Documentation of their diagnosis and mutation status

Participants will have an initial evaluation. This will include repeats of screening tests. It will also include:

Neurological exam

MRS and MRI scans of the brain: Participants will lie on a table that slides into a metal cylinder. A coil or soft padding will be placed around their head. They will have a contrast agent injected into a vein. Pictures will be taken of the brain.

Participants will have follow-up visits every 2-6 month for the rest of their life. Visits will include scans.

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Eligibility

INCLUSION CRITERIA:

-Patients must have histologically confirmed glioma with IDH1 or IDH2 mutation confirmed by DNA sequencing.

-Patients must have grade II, III or IV glioma.

-Patients must have measurable disease.

-Age greater than or equal to18 years. Tumor biology of IDH-mutant gliomas are different in pediatric tumors. Therefore, children will be excluded from the study.

-Karnofsky performance greater than or equal to 60%.

-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)).

-Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

-Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results (such as allergy to gadolinium contrast, metal implants and so on).

- Pregnant women 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 c ntrast, breastfeeding should be discontinued for 72 hours following study imaging.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jing Wu, M.D.
National Cancer Institute (NCI)
NIHBC 37 BG RM 1142A
37 CONVENT DR
BETHESDA MD 20892
(240) 760-6036
jing.wu3@nih.gov

NCI NOB Referral Group
National Cancer Institute (NCI)

(866) 251-9686
ncinobreferrals@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03952598

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