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Diagnostic Study In Patients Receiving Treatment For Brain Tumors
This study is ongoing, but not recruiting participants.
Study NCT00020293   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
March 2000
 
 
 
Complete list of historical versions of study NCT00020293 on ClinicalTrials.gov Archive Site
 
 
 
Diagnostic Study In Patients Receiving Treatment For Brain Tumors
1H-Nuclear Magnetic Resonance Spectroscopic Imaging of the Brain in Patients Who Receive Neurotoxic Therapy

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.

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.

 
Interventional
Diagnostic
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Procedure: magnetic resonance spectroscopic imaging
  • Radiation: gadopentetate dimeglumine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020293
 
CDR0000068229, NCI-99-C-0088
National Cancer Institute (NCI)
 
Study Chair: Katherine Warren, MD NCI - Pediatric Oncology Branch
National Cancer Institute (NCI)
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP