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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
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 31, 2019
    Last Updated
    November 8, 2019
    Sponsor
    University of Aarhus
    Collaborators
    GCP-unit at Aarhus University Hospital, Aarhus, Denmark, REDCap
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    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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