Overview

Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation

Status:
Unknown status
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
The propose of this prospective study focuses on the role of [18F]FES PET imaging in patients with breast cancer who might receive or are receiving hormone therapy. First, we will develop and optimize the radiosynthesis and quality control tests of [18F]FES in conditions that meet good manufacturing practice (GMP) requirements. Secondly, patients with or without metastatic breast cancer will be enrolled for the conduction of human study. [18F]FES PET imaging will be performed on patients before the initiation of hormone therapy to predict the prognosis and therapeutic response to hormone therapy. The [18F]FES PET results will be compared with ER status obtained by immunohistochemical (IHC) staining on surgically obtained specimens. Moreover, in patients with progression of metastatic disease, the [18F]FES PET will be correlated with ESR1 gene mutation, which is one of the mechanisms for resistance to hormone therapy.
Phase:
Phase 3
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate