Clinical trial · Interventional
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
NCT05613270CI-TRIAL-00062171unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FES PET/CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FES PET/CT
- description
- Inject 18F-FES and then perform PET/CT scan.
- interventionNames
- Diagnostic Test: 18F-FES PET/CT scan
Primary outcomes (3)
- measure
- Standardized uptake value of 18F-FES in BC
- timeFrame
- through study completion, an average of 1 year
- description
- The max standard uptake value (SUVmax) was measured in the breast cancer lesions on 18F-FES PET/CT.
- measure
- Lesions detected by 18F-FES PET/CT
- timeFrame
- through study completion, an average of 1 year
- description
- The number of target lesions was calculated by 18F-FES PET/CT.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYao 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. PMID 42078117