Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
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.