Characterizing Breast Cancer With 18F-FES PET/CT

Breast Cancer Clinical Trial

Official title:

A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613270
• Other study ID #: PekingUMCH-FES-BC-1
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Peking Union Medical College Hospital
• Contact: Zhixin Hao, M.D.
• Phone: +86-18401649136
• Email: zxhaonm[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• 18F-FES PET/CT scan
Patients with suspected metastatic ER-positive breast cancer underwent 18F-FES PET/CT after an injection of 185-222 MBq (5-6 mCi) 18F-FES to image lesions of metastatic breast cancer.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value of 18F-FES in BC	The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.	through study completion, an average of 1 year
Primary	Lesions detected by 18F-FES PET/CT	The number of target lesions was calculated by 18F-FES PET/CT.	through study completion, an average of 1 year
Primary	Compared with 18F-FDG PET/CT	The number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.	through study completion, an average of 1 year
Secondary	Overall survival	Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy	3 years