Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 主要终点
- Number of image guided prostate biopsy in the zones detected by the TEP scan
研究概览
简要总结
Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).
The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with suspicion of prostate cancer
- •Patients who performed prostate mpMRI and F-Choline 18 PET scan
- •Patient capable of receiving clear informations
- •Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
- •Patient covered by a healthcare insurance
排除标准
- •Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan
研究组 & 干预措施
Prostate cancer/mpMRI
干预措施: mpMRI (Device)
Prostate cancer/TEP scan
干预措施: PET Scan ou TEP-TDM (Device)
结局指标
主要结局
Number of image guided prostate biopsy in the zones detected by the TEP scan
时间窗: at inclusion
次要结局
- Number of image guided prostate biopsy in the zones detected by the mpMRI(at inclusion)