Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8
研究概览
简要总结
The goal of this clinical trial is to test the imaging and diagnostic ability of [68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions it aims to answer are:
- Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with different stages.
- The safety of [68Ga]-NOTA-SGC8. Participants will be irrigated with [68Ga]-NOTA-SGC8 into the bladder for tumor imaging under PET/MR. The imaging performance of [68Ga]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated by combining with pathological sections of patients. Urine accumulation and radioactivity distribution of [68Ga]-NOTA-SGC8 will be measured. The adverse events will be recorded.
详细描述
Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.
To evaluate the efficacy of [68Ga]-NOTA-SGC8 in imaging bladder tumors, the following indexes will be measured: specific imaging of the tumor area; specific imaging of its target PTK7 receptor protein; distribution in major organs; PET/MR imaging after administration; the absorbed dose of internal radiation based on the reference human hormone model using OLINDA software.
Tumor tissues of patients will be collected, and pathological sections of relevant patients will be analyzed after surgery. Immunohistochemistry will be used to verify the expression of PTK7 receptor in corresponding tumors. The association between PTK7 receptor protein and tumor malignancy, invasion, and stage will be evaluated by molecular imaging results.
All adverse events will be recorded within 24 hours after the administration of [68Ga]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24 hours to 5 days after intravesical infusion. Blood and urine samples will be collected and the concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed or previously diagnosed bladder tumors.
- •At least one cystoscopy was performed within one month prior to enrollment, and the clinical diagnosis of bladder tumor was present.
- •Age > 18 years, < 80 years
- •Patients voluntarily participate and sign informed consent and are willing and able to follow protocol requirements.
排除标准
- •Pregnancy, lactation, severe liver and kidney insufficiency and children;
- •Participants who are allergic to the experimental drug, have an allergic disposition, or are allergic to multiple drugs.
结局指标
主要结局
Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8
时间窗: 2 year
Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation
Tumor specific lighting ability of [68Ga]-NOTA-SGC8
时间窗: 2 year
Number of patients whose tumors are lightened under PET/MR with \[68Ga\]-NOTA-SGC8
次要结局
- Staging ability of [68Ga]-NOTA-SGC8(2 year)
- The expression of PTK7 in bladder tumor tissues(2 year)