Clinical trial · Interventional
The Value of 18F-FES-PET/CT in Predicting Fulvestrant Efficacy in Breast Cancer
The Value of 18F-FES-PET/CT in Predicting the Efficacy of Fulvestrant as First-line Treatment in Postmenopausal Patients With Hormone Receptor-positive Advanced Breast Cancer - a Multicenter Prospective Study
NCT03768479CI-TRIAL-00036084PETunknownN/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)
This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in hormone receptor-positive breast cancer. The imaging agent involved in this study is 16α-\[18F\]-fluoro-17β-estradiol (18F-FES).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Fulvestrant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FES-PET | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FES-Fulvestrant
- description
- Patients with ER positive breast cancer receive Fulvestrant as the first line treatment enrolled in the study would receive 18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant.
- interventionNames
- Device: 18F-FES-PET
Primary outcomes (1)
- measure
- the change percentage of 18F-FES SUV
- timeFrame
- At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)
- description
- The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment
Secondary outcomes (1)
- measure
- The correlation between the change percentage of 18F-FES SUV and the clinical efficacy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Be at least 18 years or older (required for legal consent) * Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A) * Pathologically diagnosed metastatic breast cancer * Fulvestrant used as the first-line treatment * Have primary breast tumor that is at least 2 cm in diameter as measured in any dimension on either mammogram, ultrasound, or breast MRI * Have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: General Exclusion Criteria * Previously treated metastatic breast cancer * Concurrent malignancy of any type * Impaired elimination (as defined as having problems with urination) * Participation in a research study/studies involving radiation exposure within the past 12 months * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, major kidney or liver disease, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnancy * Currently lactating (either breast feeding or breast pumping) General PET/CT Safety Exclusion Criteria: * Electrical implants such as cardiac pacemakers or perfusion pumps * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing * Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest * Inability to lie comfortably on a bed inside a PET camera for 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis) * Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure for female subjects of child-bearing age.
References
Publications (1)
- RESULTvan Kruchten M, de Vries EG, Glaudemans AW, van Lanschot MC, van Faassen M, Kema IP, Brown M, Schroder CP, de Vries EF, Hospers GA. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015 Jan;5(1):72-81. doi: 10.1158/2159-8290.CD-14-0697. Epub 2014 Nov 7. PMID 25380844