Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results
This is the first belgian feasibility study of HER2 imaging using a labelled monoclonal
antibody, namely trastuzumab labelled with zirconium 89.
The aims of this study are:
I/ Evaluate the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab
(based on the Groningen experience), through the analysis of the correlation between the
FDG-PET/CT and the HER2 immunoPET.
II/ PET quantification of HER2 receptor by using the images and the blood pharmacokinetic of
III/ In the subset of patients for whom biopsies of metastatic sites have not been carried
out previously and are of an easy access, tissue will be acquired as part of the validation
of the HER2 immunoPET and as an attempt to better understand the molecular heterogeneity of
HER2 positive breast cancer at the time of relapse.
IV/Evaluate the concentration of circulating HER2 extracellular domain in the blood and
study his possible role as on imaging quality
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Test the diagnostic accuracy of the HER2 imaging using the labelled monoclonal antibody trastuzumab by correlating the HER2 PET/CT imaging with the FDG-PET/CT and molecular characterization of tumor samples with discordant image findings
Patrick Flamen, MD, PhD
Jules Bordet Institut
Belgium: Federal Agency for Medicinal Products and Health Products