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

PHASE3CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
Recurrent Breast CancerStage IV Breast Cancer
Interventions
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.

Trial Locations (1)

138-736

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT01986569 - Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter