89Zr-atezolizumab PET Scan and Lobular Breast Cancer
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 12/31/2019 |
| Primero enviado: | 04/22/2019 |
| Inscripción estimada enviada: | 01/06/2020 |
| Publicado por primera vez: | 01/09/2020 |
| Última actualización enviada: | 01/06/2020 |
| Última actualización publicada: | 01/09/2020 |
| Fecha de inicio real del estudio: | 12/17/2019 |
| Fecha estimada de finalización primaria: | 04/30/2021 |
| Fecha estimada de finalización del estudio: | 04/30/2021 |
Condición o enfermedad
Intervención / tratamiento
Other: 89Zr-atezolizumab PET scan
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: 89Zr-atezolizumab PET scan All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. The 89Zr-atezolizumab PET scan will be performed 4 days after tracer injection. Procedures within the ImaGelato study will be completed after the two 89Zr-atezolizumab PET scans, but patients will continue treatment with carboplatin combined with atezolizumab in the GELATO trial. | Other: 89Zr-atezolizumab PET scan Patients receive a total amount of 10 mg unlabeled atezolizumab, this will be added to the tracer to prevent rapid clearance during imaging. A labeled dose of 37 Megabequerell (MBq) 89Zr-atezolizumab (±10%; 1 Millicurie) will then be administered. The tracer will be administered intravenously (i.v.). All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. After each tracer injection, 89Zr-atezolizumab PET scans will be performed on day 4 (96 ± 6h after tracer administration). |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. A patient must meet the inclusion criteria of the GELATO trial 2. Able to give written informed consent and to comply with the ImaGelato protocol Exclusion Criteria: 1. Contra-indication for 89Zr-atezolizumab PET scan 2. Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to the first 89Zr-atezolizumab injection. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89Zr-atezolizumab injection. |
Salir
Medidas de resultado primarias
1. Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value [2 years]
Medidas de resultado secundarias
1. The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab [2 years]
2. The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments [2 years]
