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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05613270
Enrollment
50
Registered
2022-11-14
Start date
2021-05-01
Completion date
2024-12-31
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DIAGNOSTIC_TEST18F-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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Standardized uptake value of 18F-FES in BCthrough study completion, an average of 1 yearThe max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.
Lesions detected by 18F-FES PET/CTthrough study completion, an average of 1 yearThe number of target lesions was calculated by 18F-FES PET/CT.
Compared with 18F-FDG PET/CTthrough study completion, an average of 1 yearThe number of lesions detected by 18F-FES PET/CT was compared with 18F-FDG PET/CT.

Secondary

MeasureTime frameDescription
Overall survival3 yearsEvaluate overall survival (OS) in patients receiving regimens containing endocrine therapy

Countries

China

Contacts

Primary ContactZhixin Hao, M.D.
zxhaonm@outlook.com+86-18401649136
Backup ContactLi Huo, M.D.
huoli@pumch.cn+86-13910801986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026