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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150731
• Other study ID #: 2020FES
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 23, 2020
• Est. completion date: June 28, 2023

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 28, 2023
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• 16a-18F-fluor-17ß-estradiol
16a-18F-fluor-17ß-estradiol PET/CT scan

Locations

Country	Name	City	State
Denmark	Department of Nuclear Medicine & PET Centre, Aarhus University Hospital	Aarhus N

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	GCP-unit at Aarhus University Hospital, Aarhus, Denmark, REDCap

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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