Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases+5

+ Central Nervous System Diseases

+ Neoplasms

Until 21 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 1997
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: May 8, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: March 14, 1997

Actual date on which the first participant was enrolled.

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.

Principal SponsorNational Cancer Institute (NCI)
Last updated: May 8, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsCentral Nervous System NeoplasmsBrain Neoplasms

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center