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

7 maggio 2019 aggiornato da: National Cancer Institute (NCI)

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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Maryland
  - Bethesda, Maryland, Stati Uniti, 20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 21 anni (Bambino, Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors. Lasso di tempo: at time of disease evaluation	in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect	at time of disease evaluation

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema Lasso di tempo: at time of disease evaluation	measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)	at time of disease evaluation
Determine if early metabolic changes are predictive of response Lasso di tempo: at time of disease evaluation	Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery	at time of disease evaluation

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

14 marzo 1997

Completamento dello studio

6 maggio 2019

Date di iscrizione allo studio

Primo inviato

3 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità