(1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy
|Study Design:||Time Perspective: Prospective|
|Official Title:||(1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy|
- Identify patterns of brain metabolites associated with therapy related neurotoxicity [ Time Frame: At time of MRI and till date of death ] [ Designated as safety issue: No ]
|Study Start Date:||April 1999|
- Central nervous system toxicity is a recognized side effect of certain cancer therapies, particularly cranial irradiation, intrathecal therapy and systemic high-dose chemotherapy.
- The pathophysiologic mechanisms are not well-defined 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.
-To identify specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using (1)H-NMRS in cancer patients who are receiving or have received potentially neurotoxic therapy.
-Patients with brain tumors or patients receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiation therapy OR patients with documented or suspected clinical neurotoxicity presumed to be caused by treatment for cancer.
- In order to identify metabolite profiles that may be associated with neurotoxicity, NMRS data will be collected in a cross-sectional manner from patients at various stages of treatment and longitudinally throughout the course of therapy.
- NMRS studies will be performed on patients entered on this study at any or all of the following times: prior to therapy, immediately after the first cycle of therapy, prior to subsequent cycles of therapy, or after completion of all therapy.
- Neurotoxicity will also be evaluated by neuropsychological testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001807
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Katherine E Warren, M.D.||National Cancer Institute (NCI)|