A Multicenter, Open-access, Self-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mTc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignancies.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor. Objective: To evaluate the safety of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor. Objective: To explore the diagnostic threshold of technetium [99mTc]-H7ND injection for peritoneal metastasis of gastrointestinal malignant tumor.
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
- •Only those who meet all the following requirements are eligible to join the group:
- •Adults over 18 years of age (based on the time when the informed consent form was signed) can be male or female;
- •Subjects with gastrointestinal malignant tumor confirmed by histology/cytology;
- •Subjects to be surgically removed or explored;
- •The estimated survival time is ≥12 weeks;
- •Subjects of childbearing age agreed to adopt effective contraceptive measures during the study period;
- •Subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, voluntarily participate in and sign a written informed consent, and are willing to follow the requirements of the protocol to complete the study.riteria:
- •Those who meet one of the following items are not allowed to join the group:
- •According to the researcher's judgment, during the screening period, from the imaging examination to the comprehensive real diagnosis information result, the patients were treated with anti-digestive tract tumor;
- •symptomatic brain metastases who need treatment;
- •Have serious cardiovascular and cerebrovascular diseases;
- •There are other contraindications for imaging examination of the research plan, such as claustrophobia;
- •Have a history of other malignant tumors;
- •Pregnant (pregnancy test positive in screening period) or lactating women;
- •Other circumstances that the researcher considers inappropriate to participate in this clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Patients with malignant tumors of the gastrointestinal tract
干预措施: Technetium [99mTc]-H7ND injection (Drug)
结局指标
主要结局
To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor
时间窗: 1-7 days from time of injection
To evaluate whether the sensitivity of 99mTc-H7ND SPECT/CT in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor is better than that of enhanced CT by SOT.
次要结局
未报告次要终点