HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma
89Zr-trastuzumab injection
Enfermedades de la Mama+2
+ Neoplasias
+ Neoplasias por Sitio
Estudio Diagnóstico
Resumen
Fecha de inicio: 1 de marzo de 2013
Fecha en la que se inscribió al primer participante.Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool. In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio Diagnóstico
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as: HER2 immunohistochemical score of 3+, or HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification. In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma: in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET. Age >18 years of age. WHO performance status 0-2. Signed written informed consent. Able to comply with the protocol. Exclusion Criteria: Pregnant or lactating women. Prior allergic reaction to immunoglobulins or immunoglobulin allergy. Inability to comply with study procedures
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación