NCT01420146

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Breast Neoplasms
• Secondary
• HER2 Positive Carcinoma of Breast

Interventions

Type	Name	Description
DRUG	Zr89-trastuzumab	trastuzumab labelled with zirconium 89 for PET/CT

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2011-08-19
• Last updated: 2017-04-18
• Results posted: 2017-04-18

Locations

1 site across 1 country: Belgium