Protocol Number: 97-C-0093

Title:

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

Number:

97-C-0093

Summary:

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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 (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 sign a written 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, aneurysmal clips, shrapnel, cochlear implants or ferrous surgical clips.

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

Special Instructions: Currently Not Provided

Keywords:

Non-Invasive

Children

Metabolites

Multivoxel

Multislice

Recruitment Keywords:

None

Conditions:

Brain Neoplasm

Neoplasm Metastasis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

Clinical applications of proton MR spectroscopy

Proton magnetic resonance spectroscopy of pediatric brain tumors

Multislice proton spectroscopic imaging of the human brian

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Warren Grant Magnuson Clinical Center (CC)
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Bethesda, Maryland 20892. Last update: 10/27/2004