Clinical Trial: (1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients who Receive Neurotoxic Therapy

This study is no longer recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

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.

Condition
Cancer
Central Nervous System Disease
Nervous System Disease
Peripheral Nervous System Disease
Progressive Multifocal Leukoencephalopathy

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Encephalitis;   Neurologic Diseases;   Peripheral Nerve Disorders;   Viral Infections

Study Type: Observational
Study Design: Natural History

Further Study Details: 

Expected Total Enrollment:  50

Study start: April 15, 1999

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

Genders Eligible for Study:  Both

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.

Location Information


Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

More Information

Detailed Web Page

Publications

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.

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.

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.

Study ID Numbers:  990088; 99-C-0088
Record last reviewed:  February 28, 2005
Last Updated:  March 4, 2005
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001807
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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