Breast cancer mammary carcinoma.
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically proven metastatic ER+ (>10% positive stained cells usingimmunohistochemistry) breast cancer on the latest biopsy - Postmenopausal females aged 18 years or older at screening. Postmenopausal status is defined as one of the following: a. age >=60 years b. age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists) c. patient age <60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures d. previous bilateral oophorectomy or medically confirmed ovarian failure - [18F]FDG PET, CT and/or a bone scan should be performed as part of routine clinical staging (=30 ml/min - Written and signed informed consent
Exclusion criteria
Exclusion criteria: - History with another cancer within the last 5 years, except cancer treated with curative intent and no evidence of disease as judged by the treating physician. - Use of selective estrogen receptor modulators (SERMs) or downregulators (SERDs) for current breast cancer such as Tamoxifen/Fulvestrant (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - part A: the most optimal pharmacokinetic model (for instance the single tissue reversible, two tissue reversible or irreversible model) will be identified. Depending on the model, the most robust and stable parameter for quantification of tracer uptake in tumor lesions (for instance the net influx rate (Ki) or volume of distribution (VT)) will be correlated with standardized uptake values (SUVs) and tumor-to-blood ratios (TBRs). - part B: repeatability of simplified measures of [18F]FES uptake, i.e. SUVs and TBRs, will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed