Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics
RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment.
PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.
Visão geral do estudo
Status
Condições
Descrição detalhada
OBJECTIVES:
- To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology.
- To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery.
OUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy.
Patients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies.
Breast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings.
The study interventions are discontinued after definitive surgery is performed.
PROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
- Women with breast tumors planning to undergo surgical resection
- Healthy volunteers, including any constitutionally healthy female with no history of breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not acutely ill
- No non-magnetic resonance-compatible ferromagnetic materials present in the body
PRIOR CONCURRENT THERAPY:
- Prior chemotherapy and/or radiotherapy allowed
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
|
at the time of each procedure.
Outros nomes:
removal of breast tumor or removal of the entire breast in which the tumor is located
Outros nomes:
Prior to initiation of treatment
Outros nomes:
After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
Outros nomes:
Prior to initiation of treatment
Outros nomes:
|
|
Sem intervenção: Healthy volunteers
Women without breast cancer undergo DCE-MRI and MRS.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Correlation of data obtained by DCE-MRI and magnetic resonance spectroscopy (MRS) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology in women with breast cancer
Prazo: At time of breast surgery
|
Imaging and spectroscopic studies are performed before surgery.
After surgery, this data will be compared and contrast with data obtained from conventional mammograms and the patient's tissue.
|
At time of breast surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer
Prazo: After the last scan
|
Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy.
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After the last scan
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: A. Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VICC BRE 0358
- P30CA068485 (Concessão/Contrato do NIH dos EUA)
- VU-VICC-BRE-0358
- VU-VICC-IRB-030472
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