FES (16a-[18F]-fluoro-17ß-estradiol)-PET: Towards a new standard to stage clinical stage II/III and recurrent, estrogen receptor positive (ER+) breast cancer? Pilot study to compare [18F]FES-PET and [18F]FDG-PET. - FORESIGHT

VU University Medical Center0 个研究点目标入组 40 人开始时间: 2018年10月3日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•- Clinical stage II/III or LRR breast cancer (all histological types) with ER+ and low grade according to Bloom Richardson criteria (grade 1-2)
•- Females aged 18 years or older at screening
•- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
•- Candidates for treatment with curative intent (patients are also allowed for inclusion in the current study if they have undergone recent surgery (<6
•weeks) for current breast cancer and require staging because of unexpected stage III disease)
•- [18F]FDG PET/CT imaging should be performed for staging according to standard of care (in case [18F]FDG PET/CT imaging has already been performed, patients can be included =21 days after this scan)
•- 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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- History with another cancer within the last 5 years, except non-melanoma skin cancer
•- Undergoing treatment for current breast cancer such as (neo)adjuvant chemotherapy, hormonal therapy (only in case of Tamoxifen), radiotherapy 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

发起方

VU University Medical Center