Dynamic and test-retest whole body [18F]FES PET imaging in patients with metastatic ER+ breast cancer.
- Conditions
- Metastatic ER+ breast cancer.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000610-42-NL
- Lead Sponsor
- Amsterdam UMC - location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 15
- 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
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
- 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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method