16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Radiation: 16α-18F-fluor-17β-estradiol
- Registration Number
- NCT04150731
- Lead Sponsor
- University of Aarhus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Breast cancer and FES 16α-18F-fluor-17β-estradiol Only one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done
- Primary Outcome Measures
Name Time Method Sensitivity of parametric FES-PET/CT 1 year Examine the sensitivity of parametric FES-PET/CT compared to conventional FES-PET/CT to detect estrogen receptor (ER) positive liver metastases
- Secondary Outcome Measures
Name Time Method Examination of the heterogeneity of ER expression in liver metastases 1 year Examine intra-individual heterogeneity of ER expression in liver metastases by FES-PET/CT
Correlation of tumor blood flow to ER+ cells 1 year Correlate tumor blood flow measured by H215O-PET/CT to the percentage of ER+ cells, measured by both FES-PET/CT and Visiopharm technology
Correlation of ER expression 1 year Correlate the ER expression in metastases measured by parametric FES-PET/CT to Visiopharm H-score on biopsy material examined by immunohistochemistry (IHC)
Examination of the heterogeneity of ER expression i metastases 1 year Examine intra-individual heterogeneity of ER expression in metastases in different tissues by FES-PET/CT
Examination of the heterogeneity of ER expression 1 year Examine the heterogeneity of the ER expression between primary tumor and metastases by FES-PET/CT
Trial Locations
- Locations (1)
Department of Nuclear Medicine & PET Centre, Aarhus University Hospital
🇩🇰Aarhus N, Denmark