Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

OBJECTIVES: - Determine the specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using 1H-nuclear magnetic resonance spectroscopic imaging in patients with cancer. 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.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of brain tumor OR - Receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiotherapy OR - Documented or suspected clinical neurotoxicity presumed to be caused by anticancer treatment - No preexisting neurologic or genetic conditions unrelated to tumor PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant - Negative pregnancy test - No braces or permanent retainers - No metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants, or ferrous surgical clips - No physical or psychological factor that would preclude imaging studies - No history of severe reaction to gadolinium PRIOR CONCURRENT THERAPY: Biologic therapy: - Concurrent immunotherapy allowed Chemotherapy: - See Disease Characteristics - Concurrent chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - Concurrent radiotherapy allowed Surgery: - Not specified


NCT ID:

NCT00020293


Primary Contact:

Study Chair
Katherine Warren, MD
NCI - Pediatric Oncology Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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