NL-OMON53628尚未招募不适用
The diagnostic value of FAPI PET/CT in staging of newly diagnosed PCa - proFAPI
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Male, aged >= 18 years;
- •- WHO performance status 0, 1 or 2;
- •- Written informed consent;
- •- Biopsy-proven newly diagnosed PCa;
- •- International Society of Urological Pathology (ISUP) grade group (GG) >= 3
- •and/or PSA >= 20 ng/ml and/or >=cT3a.
- •If all of the criteria above are met, a subject must also meet all of the
- •following subgroup specific criteria:
- •Group 1 (n=15):
- •- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or
- •distant metastases.
- •Group 2 (n=15):
- •- PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or
- •distant metastases;
- •- Increased risk of nodal metastases according to the Briganti 2019 nomogram
- •(Briganti >=40%)
- •- Scheduled for (laparoscopic) prostatectomy including ePLND.
排除标准
- •- Known second malignant disease that may complicate image interpretation.
- •- Inability to cooperate with the scan process: inability to lie relatively
- •still and in supine for 30-60 minutes or patient body habitus above scanner
- •dimensions.
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