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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: 16α-18F-fluor-17β-estradiol

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Department of Nuclear Medicine & PET Centre, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast cancer and FES; 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; 16α-18F-fluor-17β-estradiol PET/CT scan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: GCP-unit at Aarhus University Hospital, Aarhus, Denmark; REDCap
• Investigators: Principal Investigator: Mette A Pedersen, MD, Department of Nuclear Medicine & PET-centre. Aarhus University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; Liver metastases; FES-PET/CT; Dynamic scan
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: 2020FES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No