Know Cancer

or
forgot password

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


N/A
N/A
N/A
Open (Enrolling)
Both
Cancer, Central Nervous System Disease, Nervous System Disease, Peripheral Nervous System Disease, Progressive Multifocal Leukoencephalopathy

Thank you

Trial Information

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


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


- 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Katherine E Warren, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

990088

NCT ID:

NCT00001807

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Cancer
  • Central Nervous System Disease
  • Nervous System Disease
  • Peripheral Nervous System Disease
  • Progressive Multifocal Leukoencephalopathy
  • Neuroimaging
  • Leukoencephalopathy
  • Cortical Atrophy
  • Methotrexate
  • Radiation
  • Central Nervous System Diseases
  • Leukoencephalopathy, Progressive Multifocal
  • Nervous System Diseases
  • Peripheral Nervous System Diseases
  • Leukoencephalopathies

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892