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Trastuzumab

Antineoplastic Agents, Immunological

trastuzumab labelled with zirconium 89 for PET/CT

Zr89-trastuzumab

Patrick Flamen, MD, PhD

Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.

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

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results

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 of normal organ and tumor lesions: pharmacokinetic

evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality

Jules Bordet Institute

Zr89-trastuzumab PET/CT single arm

Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT

Zr89-trastuzumab PET/CT

Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm

Age, Categorical

Sex: Female, Male

Belgium

Region of Enrollment

Dr Géraldine Gebhart

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients	NCT01420146	Breast Neoplasm... Secondary HER2 Positive C...	Zr89-trastuzuma...	18 Years -	Jules Bordet Institute
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients	NCT01420146	Breast Neoplasm... Secondary HER2 Positive C...	Zr89-trastuzuma...	18 Years -	Jules Bordet Institute

Spots Global Cancer Trial Database for her2 positive carcinoma of breast