NCT06419348招募中早期 1 期
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET
First Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy
研究概览
简要总结
99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent imaging agent applicable to PSMA positive prostate cancer. This study will investigate the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging for the diagnosis of lesions in PSMA positive prostate cancer.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age.
- •Signed informed consent.
- •Patients with suspected or newly diagnosed or previously prostate cancer, with PSMA positive expression (supporting evidence may include MRI, CT, and pathology report, etc).
排除标准
- •Patients with PSMA negative expression.
- •Patients with pregnancy.
- •The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
- •Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components.
- •Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
研究组 & 干预措施
99mTc-QULIC-5-P1
Experimental
Patients will receive a single administration of 99mTc-QULIC-5-P1
干预措施: 99mTc-QULIC-5-P1 (Drug)
结局指标
主要结局
Diagnostic efficacy
时间窗: 15 days
The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT
次要结局
未报告次要终点
研究者
Xiaoyang Zhang
Principal Investigator
First Affiliated Hospital of Chongqing Medical University
研究点 (1)
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