16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
16α-18F-fluor-17β-estradiol
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, Liver metastases, FES-PET/CT, Dynamic scan
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breast cancer and FES
Arm Description
Only one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Examination of the heterogeneity of ER expression in liver metastases
Examine intra-individual heterogeneity of ER expression in liver metastases by FES-PET/CT
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
Examination of the heterogeneity of ER expression
Examine the heterogeneity of the ER expression between primary tumor and metastases by FES-PET/CT
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
Full Information
NCT ID
NCT04150731
First Posted
October 31, 2019
Last Updated
November 8, 2019
Sponsor
University of Aarhus
Collaborators
GCP-unit at Aarhus University Hospital, Aarhus, Denmark, REDCap
1. Study Identification
Unique Protocol Identification Number
NCT04150731
Brief Title
16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
Official Title
16α-18F-fluor-17β-østradiol PET/CT Til Visualisering af østrogenreceptor-positive Levermetastaser Fra brystkræft
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
GCP-unit at Aarhus University Hospital, Aarhus, Denmark, REDCap
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Liver metastases, FES-PET/CT, Dynamic scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer and FES
Arm Type
Experimental
Arm Description
Only one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done
Intervention Type
Radiation
Intervention Name(s)
16α-18F-fluor-17β-estradiol
Intervention Description
16α-18F-fluor-17β-estradiol PET/CT scan
Primary Outcome Measure Information:
Title
Sensitivity of parametric FES-PET/CT
Description
Examine the sensitivity of parametric FES-PET/CT compared to conventional FES-PET/CT to detect estrogen receptor (ER) positive liver metastases
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation of ER expression
Description
Correlate the ER expression in metastases measured by parametric FES-PET/CT to Visiopharm H-score on biopsy material examined by immunohistochemistry (IHC)
Time Frame
1 year
Title
Examination of the heterogeneity of ER expression in liver metastases
Description
Examine intra-individual heterogeneity of ER expression in liver metastases by FES-PET/CT
Time Frame
1 year
Title
Examination of the heterogeneity of ER expression i metastases
Description
Examine intra-individual heterogeneity of ER expression in metastases in different tissues by FES-PET/CT
Time Frame
1 year
Title
Examination of the heterogeneity of ER expression
Description
Examine the heterogeneity of the ER expression between primary tumor and metastases by FES-PET/CT
Time Frame
1 year
Title
Correlation of tumor blood flow to ER+ cells
Description
Correlate tumor blood flow measured by H215O-PET/CT to the percentage of ER+ cells, measured by both FES-PET/CT and Visiopharm technology
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette A Pedersen, MD
Phone
+45 31411180
Email
meabpe@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mikkel Vendelbo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette A Pedersen, MD
Organizational Affiliation
Department of Nuclear Medicine & PET-centre. Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
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