Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients (IJBMNZrT003)
HER2 Positive Carcinoma of Breast
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results|
- 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time activity curve [ Time Frame: blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6 ] [ Designated as safety issue: No ]Time activity curve of normal organ and tumor lesions: pharmacokinetic
- HER2 Extracellular domain [ Time Frame: within 60 min before tracer injection ] [ Designated as safety issue: No ]evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Zr89-trastuzumab PET/CT
Zr89-trastuzumab PET/CT single arm
trastuzumab labelled with zirconium 89 for PET/CT
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 the tracer.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420146
|Contact: Geraldine Gebhart, MDemail@example.com|
|Contact: Julie Gaye, Irfirstname.lastname@example.org|
|Jules Bordet Institut||Recruiting|
|Brussels, Belgium, 1000|
|Contact: Geraldine Gebhart, MD 003225417314 email@example.com|
|Contact: Julie Gaye, Ir 003225413207 firstname.lastname@example.org|
|Principal Investigator:||Patrick Flamen, MD, PhD||Jules Bordet Institut|