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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001807
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: October 2013
  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

Study Type: Observational
Official Title: (1)H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 50
Study Start Date: April 1999
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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001807

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Katherine E Warren, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001807     History of Changes
Obsolete Identifiers: NCT00020293
Other Study ID Numbers: 990088, 99-C-0088
Study First Received: November 3, 1999
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Neuroimaging
Leukoencephalopathy
Cortical Atrophy
Methotrexate
Radiation

Additional relevant MeSH terms:
Leukoencephalopathies
Leukoencephalopathy, Progressive Multifocal
Nervous System Diseases
Central Nervous System Diseases
Peripheral Nervous System Diseases
Brain Diseases
Neuromuscular Diseases
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Central Nervous System Infections
Demyelinating Diseases

ClinicalTrials.gov processed this record on September 22, 2014