Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases
研究概览
简要总结
Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients.
The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer)
- •Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection)
排除标准
- •Previous treatment (for example TURP or hormone therapy)
- •Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)
研究组 & 干预措施
PET-MR 18F-FACBC
干预措施: histology (gold standard) (Procedure)
PET-MR 18F-FACBC
干预措施: PET-MR 18f-FACBC (Procedure)
结局指标
主要结局
Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases
时间窗: 7 days
Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases
次要结局
未报告次要终点