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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | February 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00019292 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diagnostic Imaging in Children With Primary Brain Tumors | ||||
| Official Title ICMJE | A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors | ||||
| Brief Summary | RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of brain tumors to therapy. PURPOSE: This clinical trial is studying how well MRI works in evaluating response to therapy in children with primary or metastatic brain tumors. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients undergo nuclear magnetic resonance spectroscopic (NMRS) imaging prior to therapy, immediately after the first cycle of therapy, and/or prior to subsequent cycles of therapy. After NMRS imaging, all patients are injected with IV gadolinium-DTPA and postcontrast T1-weighted images are performed. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic | ||||
| Condition ICMJE | Brain and Central Nervous System Tumors | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Warren KE, Frank JA, Black JL, Hill RS, Duyn JH, Aikin AA, Lewis BK, Adamson PC, Balis FM. Proton magnetic resonance spectroscopic imaging in children with recurrent primary brain tumors. J Clin Oncol. 2000 Mar;18(5):1020-6. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00019292 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065415, NCI-97-C-0093 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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