Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard
研究概览
简要总结
This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .
The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient, 18 years of age or older.
- •Patient is confirmed with high risk prostate cancer.
- •Patient is indicated to undergo radical prostatectomy and ePLND.
- •Patient is estimated compliant for study participation by the investigator.
- •Patient has freely given his/her informed consent to participate in this study.
排除标准
- •Patient has general or local contra-indications for radical prostatectomy.
- •Patient has active viral or fungal infection.
- •Patient previously received radiotherapy of the prostate.
- •Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.
结局指标
主要结局
To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard
时间窗: 1 YEAR
次要结局
- Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection(1 YEAR)
研究者
Giorgio Gandaglia
Assistant Professor
IRCCS San Raffaele