Tomografia por emissão de pósitrons em mulheres com câncer de mama HER2-positivo avançado
Tomografia por emissão de pósitrons com 64 Cu-DOTA-Trastuzumabe em mulheres com câncer de mama invasivo avançado HER2 positivo
RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment
PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Visão geral do estudo
Status
Condições
Descrição detalhada
PRIMARY OBJECTIVES:
I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer.
II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease.
III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.
OUTLINE:
This is a part one dose-determining study followed by a part two study. PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab at the optimal dose as determined in part one of the study.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Eligibility Part I (Determination of the cold dose)
- Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
- At least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
- The cancer must over express HER2 as determined by IHC and FISH.
- Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
- Participants must have normal cardiac ejection fraction.
Eligibility Part 2 (correlation of HER2 expression with PET uptake)
- Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
- At least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
- Participants with HER2 1+, 2+ and 3+ by IHC are eligible.
- Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
- Participants must have normal cardiac ejection fraction.
Ineligibility
- Participants who have received trastuzumab within the prior 2 months
- Participants who are not considered candidates for trastuzumab
- Metastatic disease in a single site
- No metastatic site greater than or equal to 2 cm
- Concurrent malignancy other than skin cancer
- Inability to provide informed consent
- Participants who are pregnant
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm I
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. |
Correlative studies PET images performed on a GE Discovery 16 Ste PET-CT scanner
Outros nomes:
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
Outros nomes:
Correlative Studies
Outros nomes:
Correlative studies
Outros nomes:
Correlative studies |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
Prazo: 24 hours after injection of 64 CU-DOTA-trastuzumab
|
Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). |
24 hours after injection of 64 CU-DOTA-trastuzumab
|
|
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours
Prazo: 48 hours after injection of 64 CU-DOTA-trastuzumab
|
Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). |
48 hours after injection of 64 CU-DOTA-trastuzumab
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joanne Mortimer, City of Hope Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimado)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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
- Neoplasias por local
- Neoplasias
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias da Mama
- Técnicas de investigação
- Manipulação de amostras
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Procedimentos cirúrgicos, operatórios
- Técnicas citológicas
- Citodiagnóstico
- Técnicas de diagnóstico, cirúrgico
- Técnicas de química, analíticas
- Análise de espectro
- Histocitoquímica
- Técnicas histológicas
- Técnicas imunológicas
- Biópsia
- Espectroscopia de ressonância magnética
- Imuno -histoquímica
- 2-fenil-6- (2 '-(4'-(etoxicarbonil) tiazolil)) tiazolo (3,2-b) (1,2,4) triazol
- 64Cu-DOTA-trastuzumab
Outros números de identificação do estudo
- 09101
- NCI-2010-00322 (Identificador de registro: NCI CTRP)
- BC095002 (Número de outro subsídio/financiamento: Department of Defense)
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