NCT03827317

HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer

HERPET: A Mechanistic Non-Invasive Imaging Study of HER2 Expression in Breast Cancer Using [18F]GE-226 Positron Emission Tomography

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This mechanistic study will be the first study to assess the efficacy of \[18F\]GE-226 to target HER2 expression in patients with metastatic breast cancer. The study will establish the pharmacokinetics of \[18F\]GE-226 and the optimum time-point for performing static scans in this patient population.

Detailed description

Objectives Primary: * To determine the uptake in tumour lesions and normal tissue of \[18F\]GE-226 and compare the difference between patients with HER2 positive and HER2 negative lesions. Uptake will be quantified by semi-quantitative (SUV, AUC) and fully quantitative parameters (Ki in the case of irreversible uptake, and binding potential in the case of reversible uptake) * To determine the optimal imaging time point for \[18F\]GE-226 Secondary: * To determine the safety and toxicity of \[18F\]GE-226 PET in humans * To determine if \[18F\]GE-226 can distinguish between HER2 amplified and HER2 non-amplified breast tumours * To determine the metabolism of \[18F\]GE-226 in human subjects Exploratory: • To explore circulating biomarkers that may be related to \[18F\]GE-226 uptake and to investigate if treatment modulates \[18F\]GE-226 Endpoints Secondary: * Safety and toxicity of \[18F\]GE-226 measured by adverse events from administration of \[18F\]GE-226 injection throughout the study period, and clinically significant changes from baseline measurements in serum biochemistry, haematology, coagulation, immunology, urinalysis, vital signs, ECG, injection site and physical examination findings. * The association between \[18F\]GE-226 tumour uptake and standard HER2 pathological testing (HER2 amplified and HER2 non-amplified breast tumours) * Proportion of metabolised \[18F\]GE-226 at scheduled time-points compared to baseline * Normal tissue uptake of \[18F\]GE-226 will be quantified in the appropriate regions depending on the field of view. Exploratory: • To perform preliminary biodistribution analysis, to compare \[18F\]GE- 226 uptake to \[18F\]FDG uptake in tumour lesion

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	[18F]GE-226	\[18F\]GE-226 is a radiolabelled Affibody® tracer which binds to the HER2 receptor with high affinity at a different epitope than trastuzumab. The active molecule is a 61 amino acid peptide that is modified site-specifically with one fluorobenzaldehyde molecule at the C-terminal.

Timeline

• Start date: 2019-03-08
• Primary completion: 2026-03-31
• Completion: 2026-12-31
• First posted: 2019-02-01
• Last updated: 2024-08-26

Locations

1 site across 1 country: United Kingdom