NCT04150731

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

October 31, 2019

Last Update Submit

November 28, 2023

Conditions

Breast Cancer

Keywords

Breast cancerLiver metastasesFES-PET/CTDynamic scan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Correlation of ER expression

    1 year

  • Examination of the heterogeneity of ER expression in liver metastases

    1 year

  • Examination of the heterogeneity of ER expression i metastases

    1 year

  • Examination of the heterogeneity of ER expression

    1 year

  • Correlation of tumor blood flow to ER+ cells

    1 year

Study Arms (1)

Breast cancer and FES

EXPERIMENTAL

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

Interventions

16α-18F-fluor-17β-estradiolRADIATION

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

Breast cancer and FES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine & PET Centre, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

  • Pedersen MA, Munk OL, Dias AH, Steffensen JH, Moller AL, Johnsson AL, Hansen KV, Bender D, Jakobsen S, Busk M, Gormsen LC, Tramm T, Borgquist S, Vendelbo MH. Dynamic whole-body [18F]FES PET/CT increases lesion visibility in patients with metastatic breast cancer. EJNMMI Res. 2024 Mar 4;14(1):24. doi: 10.1186/s13550-024-01080-y.

    PMID: 38436824DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mette A Pedersen, MD

    Department of Nuclear Medicine & PET-centre. Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 5, 2019

Study Start

October 23, 2020

Primary Completion

October 25, 2022

Study Completion

June 28, 2023

Last Updated

December 4, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)