Valor diagnóstico de la PET/TC con 18F-colina (PET/TC [18F]-FCH) para la detección de metástasis del cáncer de próstata.Diagnostic value of 18F-choline PET/CT for the detection of systemic prostate cancer disease. - 2008-CaP-FCH

CIS bio international, member of IBA group0 个研究点目标入组 150 人开始时间: 2011年11月11日最近更新: 2021年12月6日

适应症

试验速览

暂无简介。

•2. Age > or = 18 years
•3. De novo patient with histologically confirmed prostate cancer and high risk disease according to D’AMICO criteria: stages > or = T2c and/or PSA > or = 20 ng/ml and/or Gleason score > or = 8, or Gleason score = 7 with either predominance of grade 4 or percentage of positive biopsy > 50%
•4. Patient who has already been imaged by contrast-enhanced thoraco-abdominal CT and bone scintigraphy
•5. Patient who is able to undergo all study procedures and who has signed a written informed consent form to participate in the study
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 37

•1. Surgery within the last 4 weeks prior to the administration of [18F]-FCH
•2. History of other malignant tumor
•3. Previous radiation therapy
•4. Prostate biopsy within 4 weeks before [18F]-FCH PET/CT
•5. Concomitant medications containing choline
•6. Severe allergic reaction to any of the ingredients of the choline formulation
•7. Participation in another clinical study within one month prior to inclusion
•8. Uncooperative, in the investigator's opinion
•9. Linguistic or psychological inability to sign the informed consent form and/or take part in the study
•10. Having already participated in this clinical trial

发起方

CIS bio international, member of IBA group