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

Brain Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasm
• Brain Neoplasms
• Brain Tumor, Primary

• NCT number: NCT00001574
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: March 14, 1997
• Completion date: May 6, 2019