NCT00001807|Completed
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Sponsor study identifier
Secondary identifiers
observational
50
1 country
1
Study Start
April 16, 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
April 18, 2019
Date type not reportedThis date has not been verified as actual or estimated.
Central nervous system toxicity is a recognized side effect of certain therapies for cancers, particularly cranial irradiation, intrathecal therapy or systemic high-dose chemotherapy. The pathophysiologic mechanisms and clinical manifestations vary. Previous studies defining MRI changes and correlating these with neurocognitive deficiencies have been inconsistent. Recent advances in brain imaging may help to better define neurotoxic effects. (1)H-NMRS is a noninvasive method of obtaining in vivo biochemical information from the brain. It has been used to study patients with CNS disorders, including neuronal disorders. In this study, (1)H-NMRS will be used to objectively characterize CNS toxicities in patients with cancer who are receiving potentially neurotoxic therapies. In addition, we will retrospectively evaluate patients with known or suspected neurotoxicity associated with cancer therapy, to determine if changes in spectroscopic patterns are associated with CNS toxicity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 18, 2019
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 1999
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 1999
Actual (reported)November 4, 1999
Actual (reported)April 18, 2019
Date type not reportedThis date has not been verified as actual or estimated.
Identify patterns of brain metabolites associated with therapy related neurotoxicity
changes in spectroscopic metabolite patterns defined by neuropsychological testing or abnormalities on conventional MRI
At time of MRI and till date of death
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Brown RT, Madan-Swain A, Pais R, Lambert RG, Sexson S, Ragab A. Chemotherapy for acute lymphocytic leukemia: cognitive and academic sequelae. J Pediatr. 1992 Dec;121(6):885-9. doi: 10.1016/s0022-3476(05)80333-6.
Ochs J, Mulhern R, Fairclough D, Parvey L, Whitaker J, Ch'ien L, Mauer A, Simone J. Comparison of neuropsychologic functioning and clinical indicators of neurotoxicity in long-term survivors of childhood leukemia given cranial radiation or parenteral methotrexate: a prospective study. J Clin Oncol. 1991 Jan;9(1):145-51. doi: 10.1200/JCO.1991.9.1.145.
Katherine E Warren, M.D.
National Cancer Institute (NCI)
50 participants (actual enrollment reported by the registry).
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
April 16, 1999
Date type not reportedThis date has not been verified as actual or estimated.
Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling
Contact the study team to confirm eligibility.
Hoppe-Hirsch E, Renier D, Lellouch-Tubiana A, Sainte-Rose C, Pierre-Kahn A, Hirsch JF. Medulloblastoma in childhood: progressive intellectual deterioration. Childs Nerv Syst. 1990 Mar;6(2):60-5. doi: 10.1007/BF00307922.
Study Completion
April 18, 2019
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
April 24, 2019
Record last verified: 2019-04-18
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