Patients with metastatic breast cancer, newly found on 18F-FDG PET/CT, with or without HER2/neu overexpression or amplification (n=5) of one of the biopsied lesions.
Conditions
Interventions
Trade Name: Trastuzumab
Pharmaceutical Form: Powder for injection
Sponsors
Antoni van Leeuwenhoek Hospital-Nuclear Medicine department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histological confirmed breast cancer (5 with and 5 without HER2/neu overexpression or amplification), with a primary tumour and at least 1 distant metastatic lesion. Recent diagnostic 18F-FDG PET/CT (less than 1 month old) made at the NKI-AvL. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A medical condition (e.g. Li-Fraumeni) that would place the patient at unusual risk for development of new malignancies due to radiation. Concurrent use of investigational drug with unknown biodistribution. Present pregnancy, or the patient refuses to use an adequate contraception method if pre-menopausal. Known allergy for murine proteins (present in Trastuzumab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Use 89Zr-Trastuzumab to characterise the in vivo biodistribution of Zr89-Trastuzumab using PET imaging in the primary tumour and distant metastases, and comparing patients with Her2/neu positive breast cancer to patients with HER2/neu negative breast cancer. ;Secondary Objective: Compare the 89Zirconium tracer uptake within the primary tumour and metastases with lesions visualised on the 18F-FDG PET/ CT. And, relate circulating HER2/neu (serum HER2) concentration to 89Zr-Trastuzumab uptake in the tumour.;Primary end point(s): Describe and quantify the 89Zr-Trastuzumab biodistribution in all patients in terms of heterogeneity, dose per volume (MBq/ml), percentage of injected dose per volume tissue (%ID/ml) and Standardised Uptake Values (SUVs) based on conventional PET/CT and MAMMI PET. Relate 89Zr-Trastuzumab tumour accumulation to 18F-FDG accumulation and Serum HER2 concentration.;Timepoint(s) of evaluation of this end point: The main study endpoint is determined after all acquisitions are made and analysed, comparing the images of HER2/neu positive and breast cancer lesions. with the images of HER2/neu negative breast cancer lesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A description of the relation between uptake patterns on 18F-FDG and 89Zr-Trastuzumab PET will be provided. Additionally, the variation of serum HER2 will be related to the Zr-89 Trastuzumab accumulation in the normal tissue and tumour lesions. These data again will provide mean and variation values in Her2/neu positive and negative tumours. ;Timepoint(s) of evaluation of this end point: All endpoint will be analysed after acquisition of all images and obtaining all results from venous blood analyses. | — |
Countries
Netherlands
Contacts
Public ContactPrinciple Investigator
NKI-AVL
Outcome results
None listed