Proton Nuclear Magnetic Resonance Spectroscopic Imaging Compared With Fludeoxyglucose F 18 Positron Emission Tomography Scanning in Determining Biologic or Metabolic Tumor Activity in Young Patients With Brain Tumors - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00070512

Purpose

RATIONALE: Diagnostic procedures, such as proton nuclear magnetic resonance spectroscopic imaging and fludeoxyglucose F 18 positron emission tomography may improve the ability to detect the extent of cancer in young patients who have brain tumors.

PURPOSE: This clinical trial is studying how well proton nuclear magnetic resonance spectroscopic imaging works compared to fludeoxyglucose F 18 positron emission tomography in finding tumor activity and the extent of cancer in young patients with brain tumors.

Condition	Intervention
Brain and Central Nervous System Tumors	Drug: fludeoxyglucose F 18 Procedure: magnetic resonance spectroscopic imaging Procedure: positron emission tomography

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

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	A Comparative Study of Pediatric CNS Tumor Activity as Assessed by [18F-]-FDG PET Imaging and Proton Magnetic Resonance Spectroscopic Imaging (1H-MRSI)

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

Primary Outcome Measures:

Single timepoint comparison as assessed by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) vs nuclear magnetic resonance spectroscopy (NMRS) [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2003
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare proton nuclear magnetic resonance spectroscopic imaging (^1H-MRSI) vs fludeoxyglucose F 18 positron emission tomography (FDG PET) scanning in determining biologic or metabolic activity in pediatric patients with brain tumors.

Secondary

Correlate results of these imaging techniques with standard MRI readings and outcome in these patients.
Utilize these imaging techniques and various magnetic resonance sequences to evaluate changes over time in primary brain tumors as a result of the natural history of the lesion or therapeutic effects in these patients.

OUTLINE: Patients undergo standard MRI evaluation and proton nuclear magnetic resonance spectroscopic imaging (^1H-MRSI). Within 2 weeks after ^1H-MRSI, patients then undergo fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging. Patients may undergo repeat MRI and ^1H-MRSI scans every few months as needed. Patients undergo no more than 1 FDG PET scan per year.

Patients remain on this study for up to 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	1 Year to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Radiographically confirmed diagnosis of 1 of the following:
- Brain tumor, including, but not limited to 1 of the following:
  - High-grade glioma
  - Low-grade glioma
  - Primitive neuroectodermal tumor
  - Ependymoma
  - Brainstem glioma
- Residual abnormality (e.g., postoperatively or post-radiotherapy) of the brain
Measurable or evaluable by standard MRI or CT scan

PATIENT CHARACTERISTICS:

Age

1 to 21

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Negative pregnancy test
Must be a candidate for anesthesia if unable to undergo imaging study (either because of physical or psychological factor) without sedation
No diabetes mellitus
No steroid-induced hyperglycemia (i.e., fasting glucose greater than 150 mg/dL)
No history of a severe reaction (CTC grade 2 or greater) to gadolinium or other contrasting agents
No metallic MRI-incompatible implant, including any of the following:
- Cardiac pacemaker
- Neural pacemaker
- Aneurysmal clip
- Shrapnel
- Cochlear implant
- Ferrous surgical clip
No permanent braces, permanent retainers, or nonferrous implant that would interfere with obtaining spectroscopy in the area of the tumor, in the judgment of the principal investigator
Weight no greater than 136 kg
- Weight no greater than 70 kg for patients under age 18

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Prior chemotherapy allowed

Endocrine therapy

Concurrent steroids allowed

Radiotherapy

See Disease Characteristics
Prior radiotherapy allowed

Surgery

See Disease Characteristics
Prior surgery allowed

Other

Current treatment regimen may be continued or changed as necessary and determined by the primary physician
Concurrent anticonvulsants or other therapies allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070512

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

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

Web site for additional information This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000334841, NCI-03-C-0278
Study First Received:	October 3, 2003
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00070512
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent childhood brain stem glioma
untreated childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
untreated childhood supratentorial primitive neuroectodermal tumor
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
recurrent childhood ependymoma
recurrent childhood medulloblastoma
untreated childhood medulloblastoma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma

recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
untreated childhood cerebellar astrocytoma
childhood oligodendroglioma
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
recurrent childhood visual pathway and hypothalamic glioma
untreated childhood visual pathway and hypothalamic glioma
childhood choroid plexus tumor
childhood central nervous system germ cell tumor
childhood brain stem glioma

Study placed in the following topic categories:

Choroid Plexus Neoplasms
Neuroectodermal Tumors, Primitive
Astrocytoma
Central Nervous System Neoplasms
Ependymoma
Recurrence
Brain Neoplasms
Neuroectodermal Tumors

Medulloblastoma
Neuroepithelioma
Oligodendroglioma
Meningioma
Glioma
Choroid Plexus neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009