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Home > "(" Clinical Trials Conditions > (1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients who Receive Neurotoxic Therapy  (1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients who Receive Neurotoxic Therapy
(1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients who Receive Neurotoxic Therapy
For Condition: Cancer,Central Nervous System Disease,Nervous System Disease,Peripheral Nervous System Disease,Progressive Multifocal Leukoencephalopathy
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 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. Durable Power of Attorney (DPA) should be offered to all patients greater than or equal to 18 years of age. All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. When appropriate, the minor patient will sign a written assent. EXCLUSION CRITERIA: Pregnancy. Patients with braces or permanent retainers. Patients with pre-existing neurologic or genetic conditions, unrelated to the tumor. Patients who are unable (either because of physical or psychological factors) to undergo imaging studies and who are not a candidate for anesthesia. Patients who have an absent gag reflex or swallowing difficulties. Metallic implants, including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, cochlear implants or ferrous surgical clips. History of severe reaction to Gadolinium.
Total Enrollment: 50
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990088; 99-C-0088
Study Start Date: April 15, 1999
Record last reviewed: April 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001807
Other Central Nervous System Disease Studies:
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2. Biomarkers of Benzene Exposure in Inner City Residents
3. Evaluation and Natural History of Children with Cancer and AIDS
4. Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
5. Collaborative Study of 1,3 Butadiene Biomarkers
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(1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients who Receive Neurotoxic Therapy
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