View Clinical Trial (Medical Research Study)
A Comparative Study of Pediatric CNS Tumor Activity as Assessed by [18F-]-FDG PET Imaging and Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI)
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00070512 |
| Primary Contact: |
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Principal Investigator
Katherine Warren, MD
NCI - Pediatric Oncology Branch
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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