Dynamic and test-retest whole body [18F]FES PET imaging in patients with metastatic ER+ breast cancer.

Recruiting

Conditions: Breast cancer
mammary carcinoma.
10006291

Registration Number: NL-OMON50865

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

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 (<=4 weeks prior to screening)
- Patients should have metastases in the scanning field of view, all located
outside of the liver
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- Estimated glomerular filtration rate (eGFR) >=30 ml/min
- Written and signed informed consent

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 (<=5
weeks prior to screening) or investigational drug therapy
- Pregnancy or lactating women
- Any medical, psychological or social condition that may interfere with the
subject*s safety and participation in the study, will lead to exclusion from
this study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- part A: the most optimal pharmacokinetic model (for instance the single<br /><br>tissue reversible, two tissue reversible or irreversible model) will be<br /><br>identified.<br /><br>Depending on the model, the most robust and stable parameter for<br /><br>quantification of tracer uptake in tumor lesions (for instance the net influx<br /><br>rate (Ki)<br /><br>or volume of distribution (VT)) will be correlated with standardized uptake<br /><br>values (SUVs) and tumor-to-blood ratios (TBRs).<br /><br>- part B: repeatability of simplified measures of [18F]FES uptake, i.e. SUVs<br /><br>and TBRs, will be assessed. </p><br>

Secondary Outcome Measures