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Diagnostic Study In Patients Receiving Treatment For Brain Tumors

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020293
  Purpose

RATIONALE: New diagnostic procedures such as 1H-nuclear magnetic resonance spectroscopic imaging may be more effective than MRI in evaluating side effects of cancer therapy in patients who are receiving treatment for tumors.

PURPOSE: Diagnostic trial using 1H-nuclear magnetic resonance spectroscopic imaging and MRI of the brain in patients who are receiving cancer therapy for tumors.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: gadopentetate dimeglumine
Procedure: magnetic resonance spectroscopic imaging

MedlinePlus related topics:   Cancer    MRI Scans   

Drug Information available for:   Gadolinium dtpa   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic
Official Title:   1H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2000

Detailed Description:

OBJECTIVES:

  • Determine the specific patterns of brain metabolites that are associated with therapy-related neurotoxicity using 1H-nuclear magnetic resonance spectroscopic imaging in patients with cancer.

OUTLINE: Patients undergo 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI), followed by gadopentetate dimeglumine IV, followed by conventional magnetic resonance imaging (MRI) prior to anticancer therapy, immediately after the first course of therapy, prior to subsequent courses of therapy, and/or after completion of all therapy. Patients may also undergo age-appropriate neuropsychological testing within 1 week of 1H-NMRSI and conventional-contrast MRI.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 2 years.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of brain tumor OR
  • Receiving high-dose systemic chemotherapy, intrathecal chemotherapy (lumbar puncture or intra-Ommaya), or cranial radiotherapy OR
  • Documented or suspected clinical neurotoxicity presumed to be caused by anticancer treatment
  • No preexisting neurologic or genetic conditions unrelated to tumor

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant
  • Negative pregnancy test
  • No braces or permanent retainers
  • No metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants, or ferrous surgical clips
  • No physical or psychological factor that would preclude imaging studies
  • No history of severe reaction to gadolinium

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Concurrent immunotherapy allowed

Chemotherapy:

  • See Disease Characteristics
  • Concurrent chemotherapy allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • Concurrent radiotherapy allowed

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020293

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Katherine Warren, MD     NCI - Pediatric Oncology Branch    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068229, NCI-99-C-0088
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00020293
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific  
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Brain Neoplasms

ClinicalTrials.gov processed this record on November 20, 2008




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