Skip to main content
OpenTrials
Completed

NCT Number: NCT04150731

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Nuclear Medicine & PET Centre, Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

16α-18F-fluor-17β-estradiol

Radiation

16α-18F-fluor-17β-estradiol PET/CT scan

Primary outcomes

  1. Sensitivity of parametric FES-PET/CT

    Time frame: 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 outcomes

  1. Correlation of ER expression

    Time frame: 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)

  2. Examination of the heterogeneity of ER expression in liver metastases

    Time frame: 1 year

    Examine intra-individual heterogeneity of ER expression in liver metastases by FES-PET/CT

  3. Examination of the heterogeneity of ER expression i metastases

    Time frame: 1 year

    Examine intra-individual heterogeneity of ER expression in metastases in different tissues by FES-PET/CT

  4. Examination of the heterogeneity of ER expression

    Time frame: 1 year

    Examine the heterogeneity of the ER expression between primary tumor and metastases by FES-PET/CT

  5. Correlation of tumor blood flow to ER+ cells

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • REDCap

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 5, 2019
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.