EUCTR2009-014839-21-FR进行中（未招募）1 期
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: 2009年9月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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