EUCTR2020-003183-68-IT进行中（未招募）1 期
The Role of Imaging Guided Surgery to Improve the Detection of LymphNode metastases in Prostate Cancer Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection - PSMA-RGS
OSPEDALE SAN RAFFAELE0 个研究点目标入组 100 人开始时间: 2021年6月15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
- 100
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
- •-Male patients
- •-Age between 18 and 80 years
- •-Biopsy proven PCa with a LNI risk >5% according to the Briganti nomogram
- •-Planned to receive a RARP with an ePLND
- •-Able to understand and willing to sign a written informed consent document
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •-Receipt of neoadjuvant therapies
- •-Inability to complete the imaging examinations according to the prospective protocol
- •-Evidence of metastatic disease at conventional imaging before surgery
- •-Evidence of clinical lymphadenopathies at conventional imaging before surgery
- •-Life expectancy of less than 12 months
- •-Previous chemotherapy
- •-Previous brachytherapy or external beam radiotherapy
- •-Unstable cardiovascular disease
- •-Congestive Heart Failure (CHF)
- •-Clinically significant hepatobiliary or renal disease
- •-History of significant CNS injuries within 6 months
- •-Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
- •-Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I&S and 68Ga-PSMA)
- •-Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself
研究者
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