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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 | March 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00020293 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diagnostic Study In Patients Receiving Treatment For Brain Tumors | ||||
| Official Title ICMJE | 1H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy | ||||
| Brief Summary | RATIONALE: New diagnostic procedures such as 1H-nuclear magnetic resonance spectroscopic imaging may be more effective than MRI in evaluating side effects of cancer therapy in patients who are receiving treatment for tumors. PURPOSE: Diagnostic trial using 1H-nuclear magnetic resonance spectroscopic imaging and MRI of the brain in patients who are receiving cancer therapy for tumors. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients undergo 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI), followed by gadopentetate dimeglumine IV, followed by conventional magnetic resonance imaging (MRI) prior to anticancer therapy, immediately after the first course of therapy, prior to subsequent courses of therapy, and/or after completion of all therapy. Patients may also undergo age-appropriate neuropsychological testing within 1 week of 1H-NMRSI and conventional-contrast MRI. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 2 years. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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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 | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | |||||
| 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 | NCT00020293 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068229, NCI-99-C-0088 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 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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