Diagnostic Imaging in Children With Primary Brain Tumors - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019292

Purpose

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.

Condition	Intervention
Brain and Central Nervous System Tumors	Drug: motexafin gadolinium Procedure: magnetic resonance spectroscopic imaging

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors MRI Scans

Drug Information available for: Motexafin gadolinium Motexafin

U.S. FDA Resources

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

Primary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	February 1998

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019292

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Katherine Warren, MD

NCI - Pediatric Oncology Branch

More Information

Additional Information:

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

Publications:

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.

Warren K, Black J, Hill R, et al.: Proton magnetic resonance spectroscopic imaging in children with primary brain tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2146, 556a, 1999.

Study ID Numbers:	CDR0000065415, NCI-97-C-0093
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00019292 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

childhood brain tumor
childhood brain stem glioma

Additional relevant MeSH terms:

Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Motexafin gadolinium
Pharmacologic Actions

Brain Neoplasms
Neoplasms
Photosensitizing Agents
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Dermatologic Agents
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009