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

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.

Timeline

Start

2017-09-08

Primary completion

2020-12

Completion

2020-12-31

Drugs

Indications