Skip to main content
Clinical Trials/NCT00001574
NCT00001574
Completed
Not Applicable

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

National Cancer Institute (NCI)1 site in 1 country40 target enrollmentMarch 14, 1997

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Neoplasm
Sponsor
National Cancer Institute (NCI)
Enrollment
40
Locations
1
Primary Endpoint
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 14, 1997
End Date
May 6, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors.

Time Frame: at time of disease evaluation

in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect

Secondary Outcomes

  • Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema(at time of disease evaluation)
  • Determine if early metabolic changes are predictive of response(at time of disease evaluation)

Study Sites (1)

Loading locations...

Similar Trials