HERPET
Research type
Research Study
Full title
Main Study: A mechanistic non-invasive imaging study of HER2 expression in breast cancer using [18F]GE-226 positron emission tomography. HERPET-L Sub-Study: HERPET sub-study of [18F]GE-226 imaging at later timepoints. HERPET-D Sub-Study: A Phase 1 Study to Assess the Safety, Radiation Dosimetry and Biodistribution, and Basic Pharmacokinetics of [18F]GE-226 and Determine the Optimal Timing of Imaging in Cancer Patients – Sub-Study (HERPET-D).
IRAS ID
173991
Contact name
Laura Kenny
Contact email
Sponsor organisation
Imperial College London
Eudract number
2015-004027-31
Duration of Study in the UK
7 years, 7 months, 31 days
Research summary
HER2 is a protein expressed on 20% of breast cancers. This study will investigate a new type of scan to see if HER2 can be detected using imaging, the results will be compared to conventional biopsies. 16 patients with metastatic breast cancer (8 with HER2 positive and 8 with HER2 negative breast cancer, determined using the most recent biopsy) will be recruited. Dynamic PET imaging over 90 minutes using [18F]GE-226, which is a radiolabelled Affibody tracer which binds to the HER2 receptor, and radial artery sampling will be performed to establish the pharmacokinetic profile of the investigational tracer, [18F]GE-226 and hence determine the optimal imaging time point for [18F]GE-226 PET scans. Safety data will be collected and reviewed for 24 hours post [18F]GE-226 administration.Tumour uptake in individual metastases >cm (as well as the target lesion ≥2cm will be reported. Uptake will be compared between HER2 positive and HER2 negative tumours between patients, and between tumour and non-tumour tissue.
HERPET-D: The HERPET-D sub-study will assess the safety, radiation dosimetry, biodistribution, and basic pharmacokinetics of [18F]GE-226 and determine the optimal timing of PET image acquisition after administration of an [18F]GE-226 injection. This sub-study aims to recruit 10-14 patients including female patients with locally advanced/metastatic HER-2 positive breast cancer and male patients with HER2-expressing solid tumours. The imaging protocol involves a dynamic PET-CT scan over 8 slices (approx. 90 minutes), followed by two single whole-body PET-CT scans at 120- and 240-minutes post-administration of [18F]GE-226. Venous blood samples for pharmacokinetic analysis will be collected to establish the pharmacokinetic profile of the radiotracer, and determine the optimal timing of imaging post-injection. Safety data will be collected and reviewed for 24 hours post [18F]GE-226 administration. Tumour [18F]GE-226 uptake (quantitative measured including SUV) will be compared with the status of HER2 expression measured by IHC/FISH.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/0584
Date of REC Opinion
21 Apr 2017
REC opinion
Favourable Opinion