16α-18F-fluor-17β-estradiol PET/CT for Visualisation of Estrogen Receptor Positive Liver Metastases From Breast Cancer
NCT ID: NCT04150731
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2020-10-23
2023-06-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Breast cancer and FES
Only one arm: All included are patients with disseminated breast cancer and all have an experimental FES-PET/CT done
16α-18F-fluor-17β-estradiol
16α-18F-fluor-17β-estradiol PET/CT scan
Interventions
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16α-18F-fluor-17β-estradiol
16α-18F-fluor-17β-estradiol PET/CT scan
Eligibility Criteria
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Inclusion Criteria
* 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
* ER- metastases
* Life expectancy under three months
* Claustrophobia
* Any pain which makes it impossible to lie in the scanner for 90 minutes
18 Years
ALL
No
Sponsors
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GCP-unit at Aarhus University Hospital, Aarhus, Denmark
OTHER
REDCap
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Mette A Pedersen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nuclear Medicine & PET-centre. Aarhus University Hospital, Denmark
Locations
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Department of Nuclear Medicine & PET Centre, Aarhus University Hospital
Aarhus N, , Denmark
Countries
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References
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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.
Other Identifiers
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2020FES
Identifier Type: -
Identifier Source: org_study_id