Characterizing Breast Cancer With 18F-FES PET/CT
A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started May 2021
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 4, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 14, 2022
November 1, 2022
2.7 years
November 4, 2022
November 4, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
Overall survival
3 years
Study Arms (1)
18F-FES PET/CT
EXPERIMENTALInject 18F-FES and then perform PET/CT scan.
Interventions
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.
Eligibility Criteria
You may qualify if:
- suspected or confirmed metastatic ER-positive breast cancer;
- F-FDG PET/CT within two weeks;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Huo, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2022
First Posted
November 14, 2022
Study Start
May 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
November 14, 2022
Record last verified: 2022-11