jRCTs041240164招募中不适用
A single-center, open-label study to evaluate the safty of [68Ga] PSMA-11 PET CT in the diagnosis of prostate cancer
未提供0 个研究点目标入组 200 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
- 招募中
- 入组人数
- 200
- 主要终点
- Adverse events after administration of [68Ga]PSMA-11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 85age old under(—)
- 性别
- All
入选标准
- •Patients who have been fully informed of the study and have given their voluntary written consent based on their full understanding.
- •Patients aged 20 to 85 years at the time of consent
- •Patients diagnosed with high-risk localized prostate cancer
- •Patients with PSA recurrence after curative treatment for localized prostate cancer
- •Patients diagnosed with non-metastatic castration-resistant prostate cancer
- •Patients diagnosed with metastatic castration-resistant prostate cance
排除标准
- •Patients who have difficulty maintaining a supine position for the duration of the examination (approximately 20 minutes).
- •Patients who are otherwise deemed inappropriate by the principal investigator or co-investigator.
结局指标
主要结局
Adverse events after administration of [68Ga]PSMA-11
Including fatigue, nausea, constipation, and vomiting
次要结局
未报告次要终点
研究者
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