NCT06201741招募中不适用
A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Dosimetry
研究概览
简要总结
This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the [131I]/[18F]/[68Ga]ZT-111 in patients with PSMA positive metastatic 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old.
- •Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
- •Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
- •Willing and able to comply with all aspects of this study.
排除标准
- •Severe hepatic or renal impairment.
- •History of major surgery within the last month.
- •Participation in another concurrent clinical trial.
结局指标
主要结局
Dosimetry
时间窗: About 24hours from time of injection
Whole body and organ uptake activity
次要结局
- Incidence and severity of adverse events(From administration of [131I]/[18F]/[68Ga]ZT-111 until 1 week after injection)
研究者
研究点 (1)
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