NCT03344822Unknown2 期
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients in Comparaison of 18F-Choline PET-CT
Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年1月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- percentage of modification of management intent
研究概览
简要总结
Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET.
The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.
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
盲法说明
Even if the study has only one arm, the results of both PET imageries will be blind assessed.
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
- •high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline
排除标准
- •contraindication of 68Ga-PSMA PET-CT
结局指标
主要结局
percentage of modification of management intent
时间窗: 1 month
modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT
次要结局
未报告次要终点
研究者
研究点 (2)
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