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Diagnostic Imaging in Children With Primary Brain Tumors
This study is ongoing, but not recruiting participants.
Study NCT00019292   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
February 1998
 
  • Specific patterns of metabolites by long echo time multislice proton nuclear magnetic resonance spectroscopic imaging [ Designated as safety issue: No ]
  • Spectroscopic patterns associated with tumor progression, tumor necrosis, radiation necrosis, and tumor edema by conventional MRI [ Designated as safety issue: No ]
  • Correlation of early metabolic changes with predictive response [ Designated as safety issue: No ]
  • Specific patterns of metabolites by long echo time multislice proton nuclear magnetic resonance spectroscopic imaging
  • Spectroscopic patterns associated with tumor progression, tumor necrosis, radiation necrosis, and tumor edema by conventional MRI
  • Correlation of early metabolic changes with predictive response
Complete list of historical versions of study NCT00019292 on ClinicalTrials.gov Archive Site
 
 
 
Diagnostic Imaging in Children With Primary Brain Tumors
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of brain tumors to therapy.

PURPOSE: This clinical trial is studying how well MRI works in evaluating response to therapy in children with primary or metastatic brain tumors.

OBJECTIVES:

  • Define specific patterns of metabolites using long echo time multislice proton nuclear magnetic resonance spectroscopic imaging.
  • Attempt to distinguish spectroscopic patterns associated with tumor progression, tumor necrosis, radiation necrosis and tumor edema on conventional MRI imaging.
  • Determine if early metabolic changes are predictive of response in children with brain tumors treated with chemotherapy.

OUTLINE: Patients undergo nuclear magnetic resonance spectroscopic (NMRS) imaging prior to therapy, immediately after the first cycle of therapy, and/or prior to subsequent cycles of therapy.

After NMRS imaging, all patients are injected with IV gadolinium-DTPA and postcontrast T1-weighted images are performed.

PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.

 
Interventional
Diagnostic
Brain and Central Nervous System Tumors
  • Drug: motexafin gadolinium
  • Procedure: magnetic resonance spectroscopic imaging
 
Warren KE, Frank JA, Black JL, Hill RS, Duyn JH, Aikin AA, Lewis BK, Adamson PC, Balis FM. Proton magnetic resonance spectroscopic imaging in children with recurrent primary brain tumors. J Clin Oncol. 2000 Mar;18(5):1020-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary or metastatic brain tumor
  • Measurable or evaluable
  • Brain stem glioma patients need no prior histological diagnosis
  • Concurrent enrollment on a NIH primary brain tumor treatment trial or the Natural History or Standard Therapy protocols

PATIENT CHARACTERISTICS:

Age:

  • 21 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No cardiac pacemakers

Pulmonary:

  • Not specified

Other:

  • Not pregnant
  • No neural implants, shrapnel, or cochlear implants
  • No physical or psychological factors interfering with imaging studies
  • No contraindications to anesthesia
  • No history of severe reaction to gadolinium or other contrast agents

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Concurrent chemotherapy allowed

Endocrine therapy:

  • Concurrent immunotherapy allowed

Radiotherapy:

  • Concurrent radiotherapy allowed

Surgery:

  • No metallic implants (e.g., ferrous surgical clips)
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019292
 
CDR0000065415, NCI-97-C-0093
National Cancer Institute (NCI)
 
Study Chair: Katherine Warren, MD NCI - Pediatric Oncology Branch
National Cancer Institute (NCI)
June 2007

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