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CompletedNCT00001807Updated Apr 24, 2019

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

An observational study in Brain Cancer and Brain Neoplasms, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 4 Years to 20 Years. Per ClinicalTrials.gov, last updated 2019-04-24.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
4 Years to 20 Years
Sex
All
01

Study 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.

Read the detailed description

Background:

  • 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.

Objective:

-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.

Eligibility:

-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.

Design:

  • 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.
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Conditions studied

  • Brain Cancer
  • Brain Neoplasms

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Keywords

  • CNS directed therapy
  • Neurotoxicity
  • H-NMRS
  • MRI
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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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, shrapnel, cochlear implants or ferrous surgical clips.

History of severe reaction to Gadolinium.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
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What researchers measure

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

    Time frame: At time of MRI and till date of death

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Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
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References and documents

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. doi: 10.1016/s0022-3476(05)80333-6. PubMed 1447650 ↗
  • 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. PubMed 1985164 ↗
  • 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. PubMed 2340529 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00001807
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Apr 16, 1999
Completion
Apr 18, 2019
Last update
Apr 24, 2019

Study contacts

Katherine E Warren, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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