16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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16α-18F-fluor-17β-østradiol PET/CT Til Visualisering af østrogenreceptor-positive Levermetastaser Fra brystkræft

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: 16α-18F-fluor-17β-estradiol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast cancer and FES<br>Only one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done | Radiation: 16α-18F-fluor-17β-estradiol<br>* 16α-18F-fluor-17β-estradiol PET/CT scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of parametric FES-PET/CT | Examine the sensitivity of parametric FES-PET/CT compared to conventional FES-PET/CT to detect estrogen receptor (ER) positive liver metastases | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of ER expression | Correlate the ER expression in metastases measured by parametric FES-PET/CT to Visiopharm H-score on biopsy material examined by immunohistochemistry (IHC) | 1 year | 
| Examination of the heterogeneity of ER expression in liver metastases | Examine intra-individual heterogeneity of ER expression in liver metastases by FES-PET/CT | 1 year | 
| Examination of the heterogeneity of ER expression i metastases | Examine intra-individual heterogeneity of ER expression in metastases in different tissues by FES-PET/CT | 1 year | 
| Examination of the heterogeneity of ER expression | Examine the heterogeneity of the ER expression between primary tumor and metastases by FES-PET/CT | 1 year | 
| Correlation of tumor blood flow to ER+ cells | Correlate tumor blood flow measured by H215O-PET/CT to the percentage of ER+ cells, measured by both FES-PET/CT and Visiopharm technology | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Liver metastases, FES-PET/CT, Dynamic scan