A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001574

Purpose

Brain tumors represent the most common solid tumor of childhood. Treatment generally entails surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements routine MRI by giving chemical information in conjunction with spatial information obtained by MRI.

This study will be conducted to determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Condition	Intervention	Phase
Brain Neoplasm Neoplasm Metastasis	Procedure: Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment:	40
Study Start Date:	March 1997
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

N/A

Detailed Description:

Background:

Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease.
Children with brain tumors are generally followed by imaging studies, such as CT or MRI.
Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury.
Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo.

Objective:

To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Eligibility:

Age less than or equal to 21 years.
Patients entered on this trial will also be entered on one of the Branch's primary brain tumor treatment trials.
Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
Measurable or evaluable tumor at the time of study entry.

Design:

This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.

Eligibility

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

Criteria

INCLUSION CRITERIA:

Age less than or equal to 21 years.

Patients entered on this trial will also be entered on one of the Pediatric Oncology Branch's primary treatment trials (e.g., phenylacetate, phenylbutyrate, SU-101) or on the Natural History or Standard Therapy protocols. The patient's management will be determined by the primary treatment protocol.

Histology confirmed primary or metastatic brain tumor. Patients with a brainstem glioma are not required to have previously had a histologic diagnosis.

Measurable or evaluable tumor at the time of study entry.

Durable Power of Attorney (DPA): A DPA is required of all patients 18 - 21 years of age.

All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. When appropriate the minor patient will give verbal assent.

EXCLUSION CRITERIA:

Pregnant women.

Any patient who is unable (either because of physical or psychological factors) to undergo imaging studies and who is not an anesthesia candidate.

Any patient with a metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants or ferrous surgical clips.

Any patient with a history of a severe reaction to Gadolinium or other contrast agents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001574

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. Review. No abstract available.

Sutton LN, Wang Z, Gusnard D, Lange B, Perilongo G, Bogdan AR, Detre JA, Rorke L, Zimmerman RA. Proton magnetic resonance spectroscopy of pediatric brain tumors. Neurosurgery. 1992 Aug;31(2):195-202.

Duyn JH, Gillen J, Sobering G, van Zijl PC, Moonen CT. Multisection proton MR spectroscopic imaging of the brain. Radiology. 1993 Jul;188(1):277-82.

ClinicalTrials.gov Identifier:	NCT00001574 History of Changes
Obsolete Identifiers:	NCT00019292
Other Study ID Numbers:	970093, 97-C-0093
Study First Received:	November 3, 1999
Last Updated:	December 30, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Non-Invasive
Children
Metabolites
Multivoxel
Multislice

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012