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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FES PET/CT | Experimental | Inject 18F-FES and then perform PET/CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FES PET/CT scan | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Evaluate overall survival (OS) in patients receiving regimens containing endocrine therapy | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhixin Hao, M.D. | Contact | +86-18401649136 | zxhaonm@outlook.com | |
| Li Huo, M.D. | Contact | +86-13910801986 | huoli@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Huo, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42078117 | Derived | Yao R, Qu Y, Hao Z, Xu Y, Zhang J, Lian J, Gao L, Shen S, Mao F, Pan B, Sun Q, Huo L, Zhou Y. Rationale and Trial Design of DAWNA-FES Trial: Single-Arm Phase II Study of Endocrine Therapy With Dalpiciclib After Progression on CDK4/6 Inhibition Based on [18F]FES PET/CT in Patients With HR+/HER2- Advanced Breast Cancer. Cancer Innov. 2026 Apr 30;5(3):e70058. doi: 10.1002/cai2.70058. eCollection 2026 Jun. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |