(1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy

NCT00001807 | Completed

• 2 other identifiers: 99008899-C-0088
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer; Brain Neoplasms

Keywords

CNS directed therapy; Neurotoxicity; H-NMRS; MRI

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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, shrapnel, cochlear implants or ferrous surgical clips.
• History of severe reaction to Gadolinium.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 1447650 BACKGROUND

• 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.

  PMID: 1985164 BACKGROUND

• 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.

  PMID: 2340529 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Katherine E Warren, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: April 16, 1999
• Study Completion: April 18, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04-18

Locations

US (1)