Breast cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 18F-Fluoroestradiol
Pharmaceutical Form: Solution for injection
Sponsors
Mikkel Holm Vendelbo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with known disseminated breast cancer - Metastatic ER+ HER2- breast cancer with metastases in the liver, at least two separate foci visualised on CT - Diagnostic CT performed in connection to clinical control - Treatment with aromatase inhibitor and any additional treatments, or treatment with chemotherapy - Postmenopausal status Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Treatment with Tamoxifen or Fulvestrant completed within 5 weeks prior to FES PET/CT - ER- metastases - Life expectancy less than three months - Claustrofobia - Pain which make it impossible to lie still in the scanner for 90 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate parametric and conventional FES-PET/CT as methods of quantification of estrogen receptor (ER) expression in patients with disseminated BC;Secondary Objective: Not applicable;Primary end point(s): To examine the sensitivity measured by parametric FES-PET/CT with conventional FES PET/CT for detection of ER+ metastases in the liver;Timepoint(s) of evaluation of this end point: Ultimo 2021 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Correlate ER expression in liver metastases, measured by FES-PET/CT, with Visiopharms H-score on IHC biopsies 2. Examine intra-individual heterogeneity of ER expression in liver metastases with FES PET/CT 3. Examine intra-individual heterogeneity in metastases in different tissues with FES PET/CT 4. Examine the ER expression heterogeneity between primary tumor and metastases with FES PET/CT 5. Correlate tumor blood flow, measured ny H215O-PET/CT, to the percentage of ER+ cell nucleus, measured by both FES-PET/CT and Visiopharm technology;Timepoint(s) of evaluation of this end point: Ultimo 2021 | — |
Countries
Denmark
Contacts
Public ContactMette Abildgaard Pedersen
Aarhus University Hospital
Outcome results
None listed