Bethesda, Maryland 20892


Purpose:

RATIONALE: Diagnostic procedures, such as proton nuclear magnetic resonance spectroscopic imaging and fludeoxyglucose F 18 positron emission tomography may improve the ability to detect the extent of cancer in young patients who have brain tumors. PURPOSE: This clinical trial is studying how well proton nuclear magnetic resonance spectroscopic imaging works compared to fludeoxyglucose F 18 positron emission tomography in finding tumor activity and the extent of cancer in young patients with brain tumors.


Study summary:

OBJECTIVES: Primary - Compare proton nuclear magnetic resonance spectroscopic imaging (^1H-MRSI) vs fludeoxyglucose F 18 positron emission tomography (FDG PET) scanning in determining biologic or metabolic activity in pediatric patients with brain tumors. Secondary - Correlate results of these imaging techniques with standard MRI readings and outcome in these patients. - Utilize these imaging techniques and various magnetic resonance sequences to evaluate changes over time in primary brain tumors as a result of the natural history of the lesion or therapeutic effects in these patients. OUTLINE: Patients undergo standard MRI evaluation and proton nuclear magnetic resonance spectroscopic imaging (^1H-MRSI). Within 2 weeks after ^1H-MRSI, patients then undergo fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging. Patients may undergo repeat MRI and ^1H-MRSI scans every few months as needed. Patients undergo no more than 1 FDG PET scan per year. Patients remain on this study for up to 2 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Radiographically confirmed diagnosis of 1 of the following: - Brain tumor, including, but not limited to 1 of the following: - High-grade glioma - Low-grade glioma - Primitive neuroectodermal tumor - Ependymoma - Brainstem glioma - Residual abnormality (e.g., postoperatively or post-radiotherapy) of the brain - Measurable or evaluable by standard MRI or CT scan PATIENT CHARACTERISTICS: Age - 1 to 21 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Must be a candidate for anesthesia if unable to undergo imaging study (either because of physical or psychological factor) without sedation - No diabetes mellitus - No steroid-induced hyperglycemia (i.e., fasting glucose greater than 150 mg/dL) - No history of a severe reaction (CTC grade 2 or greater) to gadolinium or other contrasting agents - No metallic MRI-incompatible implant, including any of the following: - Cardiac pacemaker - Neural pacemaker - Aneurysmal clip - Shrapnel - Cochlear implant - Ferrous surgical clip - No permanent braces, permanent retainers, or nonferrous implant that would interfere with obtaining spectroscopy in the area of the tumor, in the judgment of the principal investigator - Weight no greater than 136 kg - Weight no greater than 70 kg for patients under age 18 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Prior chemotherapy allowed Endocrine therapy - Concurrent steroids allowed Radiotherapy - See Disease Characteristics - Prior radiotherapy allowed Surgery - See Disease Characteristics - Prior surgery allowed Other - Current treatment regimen may be continued or changed as necessary and determined by the primary physician - Concurrent anticonvulsants or other therapies allowed


NCT ID:

NCT00070512


Primary Contact:

Principal Investigator
Katherine Warren, MD
NCI - Pediatric Oncology Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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