NCT01986569

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

A Phase III, Open Label, Non-randomized, Single Center Study to Evaluate Diagnostic Accuracy and Safety of Fluorine-18 (18F) Fluoroestradiol PET/CT in the Assessment of ER Status of Recurrent or Metastatic Lesions in Patients With Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	[18F]fluoroestradiol (FES)	\[18F\]FES PET/CT will be performed 90 min (± 10 min) after administration of \[18F\]FES. Patients will undergo core needle biopsy or surgery within 15 days after \[18F\]FES PET; or patients will undergo core needle biopsy within 30 days before \[18F\]FES PET. Experienced pathologists will determine metastatic/recurrent disease, and tumor histology including IHC. Patient will undergo surgery, radiation therapy or systemic therapy according to the results of staging workup, histology and biomarkers.

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-11-18
• Last updated: 2016-12-08

Locations

1 site across 1 country: South Korea