NCT07727317尚未招募不适用
A Clinical Study to Evaluate the Diagnostic Efficacy and Safety of INR 202 PET/CT Imaging in Participants With Advanced Solid Tumors
Shanghai Zhongshan Hospital0 个研究点目标入组 30 人开始时间: 2026年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Number of detected lesions
研究概览
简要总结
This is a prospective, single-center, open-label clinical study comparing the imaging performance of INR202 PET/CT versus 18F-FDG PET/CT in participants with advanced solid tumors.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •ECOG performance status of 0 or
- •Advanced solid tumors.
- •Adequate organ functions.
- •Life expectancy ≥6 months.
- •Agreement to use contraceptive measures from the date of informed consent signing until 3 months after administration of INR202, and to avoid sperm or egg donation during this period.
- •The participant (or legal guardian, where applicable) is fully informed of the purpose and procedures of the study, is able to understand the information provided, and voluntarily signs the informed consent form.
排除标准
- •Unable to complete imaging examinations as required by the study protocol, in the investigator's judgement.
- •With a history of ≥2 malignancies within 5 years prior to administration of INR202, except for adequately treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, or superficial bladder cancer.
- •Known hypersensitivity to the active ingredient of INR202 or any of its components.
- •Any medical condition or other situation that, in the investigator's judgement, may affect safety, compliance, or study outcomes.
结局指标
主要结局
Number of detected lesions
时间窗: From Day 1 to Day 10
次要结局
- Adverse events(From Day 3 to Day 7)
研究者
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