NCT02409316

[18F]FES PET/CT in Endocrine Refractory Breast Cancer

[18F]Fluoroestradiol (FES) PET/CT Imaging to Evaluate in Vivo ER in Endocrine Refractory Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluoroestradiol (FES).

Detailed description

This study will evaluate \[18F\]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy. Imaging will occur prior to starting new therapy. Some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures. This is an observational study in that \[18F\]FES PET/CT will not be used to direct therapy decisions.

Conditions

• Estrogen Receptor Positive Breast Cancer
• Breast Neoplasm
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	[18F]FES	\[18F\]FES PET/CT scan

Timeline

• Start date: 2015-05-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2015-04-06
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study