Characterizing Breast Cancer With 18F-FES PET/CT

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05613270
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• suspected or confirmed metastatic ER-positive breast cancer;
• 18F-FDG PET/CT within two weeks;
• signed written consent.

Exclusion Criteria

• pregnancy;
• breastfeeding;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Lesions detected by 18F-FES PET/CT	through study completion, an average of 1 year	The number of target lesions was calculated by 18F-FES PET/CT.
Compared with 18F-FDG PET/CT	through study completion, an average of 1 year	The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.
Standardized uptake value of 18F-FES in BC	through study completion, an average of 1 year	The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years	Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China