Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients (IJBMNZrT003)
|ClinicalTrials.gov Identifier: NCT01420146|
Recruitment Status : Completed
First Posted : August 19, 2011
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Secondary HER2 Positive Carcinoma of Breast||Drug: Zr89-trastuzumab||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results|
|Study Start Date :||August 2011|
|Primary Completion Date :||September 2015|
|Study Completion Date :||September 2015|
Experimental: Zr89-trastuzumab PET/CT
Zr89-trastuzumab PET/CT single arm
trastuzumab labelled with zirconium 89 for PET/CT
- 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: 4 years ]A visual 'patient-based' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive' & C+D='HER2-negative'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" & 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called 'HER2-positive' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).
- 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 ]Time activity curve of normal organ and tumor lesions: pharmacokinetic
- HER2 Extracellular Domain [ Time Frame: within 60 min before tracer injection ]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 (NCT number): NCT01420146
|Jules Bordet Institut|
|Brussels, Belgium, 1000|
|Principal Investigator:||Patrick Flamen, MD, PhD||Jules Bordet Institut|