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


Phase 1
N/A
21 Years
Not Enrolling
Both
Brain Neoplasm, Neoplasm Metastasis

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Trial Information

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


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


- 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Katherine E Warren, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

970093

NCT ID:

NCT00001574

Start Date:

March 1997

Completion Date:

October 2008

Related Keywords:

  • Brain Neoplasm
  • Neoplasm Metastasis
  • Non-Invasive
  • Children
  • Metabolites
  • Multivoxel
  • Multislice
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892