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



Status:Completed
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:4 - 20
Updated:4/5/2019
Start Date:April 16, 1999

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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....

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.

- 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, shrapnel, cochlear
implants or ferrous surgical clips.

History of severe reaction to Gadolinium.
We found this trial at
1
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9000 Rockville Pike
Bethesda, Maryland 20892
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mi
from
Bethesda, MD
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