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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00001574
Enrollment
40
Registered
1999-11-04
Start date
1997-03-14
Completion date
2019-05-06
Last updated
2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer, Brain Neoplasm, Brain Tumor, Primary

Keywords

Metabolites, Proton Nuclear Magnetic Resonance Spectroscopic Imaging, Scans

Brief 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.

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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors.at time of disease evaluationin vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect

Secondary

MeasureTime frameDescription
Distinguish spectroscopic patterns associated with tumor progression, necrosis and edemaat time of disease evaluationmeasurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)
Determine if early metabolic changes are predictive of responseat time of disease evaluationContalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026