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

7 de maio de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 de estudo

Observacional

Inscrição (Real)

Contactos e Locais

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Locais de estudo

Estados Unidos
- Maryland
  - Bethesda, Maryland, Estados Unidos, 20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 21 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors. Prazo: at time of disease evaluation	in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect	at time of disease evaluation

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

14 de março de 1997

Conclusão do estudo

6 de maio de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

3 de novembro de 1999

Enviado pela primeira vez que atendeu aos critérios de CQ