Clinical trial · Interventional
16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
16α-18F-fluor-17β-østradiol PET/CT Til Visualisering af østrogenreceptor-positive Levermetastaser Fra brystkræft
- 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)
Breast cancer (BC) is the most common cancer diagnosis among women and the incidence is increasing. Prognosis and treatment are dependent on the expression of estrogen receptors (ER) in the tumor. ER status is determined by immunohistochemistry (IHC) on biopsy tissue. The ER expression can change over time and be heterogeneous. The IHC score on ER expression is subjective and can lead to intra and inter observer variability. A new computer image analysis software that can give the exact percentage of colored tumor cells on sectional tumor cuts has been developed. It is also possible to quantify the ER expression non invasive by using the tracer 16α-18F-flour-17β-estradiol (FES) and in vivo positron emission tomography (PET) scans. FES-PET/CT has a high background activity in the liver which complicates the visualization of liver metastases. Theoretically, a new whole body parametric scan method makes it possible to distinguish background activity from uptake in liver metastases. Malignant tumors often have an increased perfusion, and previous studies have found that tumors with low metabolism relative to blood flow have the longest disease free survival (DFS). To the best of our knowledge, no previous studies have examined the correlation between ER expression and blood flow.
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 |
|---|---|---|---|
| 16α-18F-fluor-17β-estradiol | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast cancer and FES
- description
- Only one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done
- interventionNames
- Radiation: 16α-18F-fluor-17β-estradiol
Primary outcomes (1)
- measure
- Sensitivity of parametric FES-PET/CT
- timeFrame
- 1 year
- description
- Examine the sensitivity of parametric FES-PET/CT compared to conventional FES-PET/CT to detect estrogen receptor (ER) positive liver metastases
Secondary outcomes (5)
- measure
- Correlation of ER expression
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with known disseminated breast cancer * Metastatic ER+ HER2- breast cancer with metastases in the liver, at least two separate liver foci visualised on CT * Diagnostic CT scan done in connection with clinical control * Treatment with aromatase inhibitors, and potential additional treatment * Postmenopausal Exclusion Criteria: * Treatment with Tamoxifen or Fulvestrant completed within 5 weeks prior to FES-PET/CT * ER- metastases * Life expectancy under three months * Claustrophobia * Any pain which makes it impossible to lie in the scanner for 90 minutes
References
Publications (1)
- DERIVEDPedersen MA, Munk OL, Dias AH, Steffensen JH, Moller AL, Johnsson AL, Hansen KV, Bender D, Jakobsen S, Busk M, Gormsen LC, Tramm T, Borgquist S, Vendelbo MH. Dynamic whole-body [18F]FES PET/CT increases lesion visibility in patients with metastatic breast cancer. EJNMMI Res. 2024 Mar 4;14(1):24. doi: 10.1186/s13550-024-01080-y. PMID 38436824