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

Amsterdam UMC - location VUmc0 个研究点目标入组 15 人开始时间: 2021年4月24日最近更新: 2021年5月10日

试验速览

暂无简介。

•- 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
•- 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

发起方

Amsterdam UMC - location VUmc