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



Status:Completed
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:4/6/2019
Start Date:March 14, 1997

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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....

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.

- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
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