Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer

Summary

The standard diagnostic workup for recurrent or metastatic breast cancer includes biopsy and determination of tumor estrogen status according to National Comprehensive Cancer Network and European Society for Medical Oncology. Immunohistochemistry (IHC) is currently the most commonly used method for determining ER status. A investigational imaging tracer named 16-alpha-\[18F\]-fluoro-17-beta-estradiol, or \[18F\]fluoroestradiol (\[18F\]FES) acts similarly in vivo to estradiol and binds to estrogen receptors (ERs). Previous studies in human have shown the efficacy of \[18F\]FES PET in detecting ER positive breast cancer without any observed toxicity. The investigators hypothesized that \[18F\]FES PET imaging can noninvasively assess ER status in recurrent or metastatic breast cancer lesion . In this study, a positive and negative percent agreement between IHC and \[18F\]FES will be determined.

Timeline

Start

2013-11

Primary completion

2016-11

Completion

2016-11

Publications

• Chae SY, Ahn SH, Kim SB, Han S, Lee SH, Oh SJ, Lee SJ, Kim HJ, Ko BS, Lee JW, Son BH, Kim J, Ahn JH, Jung KH, Kim JE, Kim SY, Choi WJ, Shin HJ, Gong G, Lee HS, Lee JB, Moon DH. Diagnostic accuracy and safety of 16alpha-[18F]fluoro-17beta-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study. Lancet Oncol. 2019 Apr;20(4):546-555. doi: 10.1016/S1470-2045(18)30936-7. Epub 2019 Mar 4.

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Indications