Clinical Trials Directory

Trials / Completed

CompletedNCT04150731

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
8 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATION16α-18F-fluor-17β-estradiol16α-18F-fluor-17β-estradiol PET/CT scan

Timeline

Start date
2020-10-23
Primary completion
2022-10-25
Completion
2023-06-28
First posted
2019-11-05
Last updated
2023-12-04

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04150731. Inclusion in this directory is not an endorsement.