A Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mtc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignant Tumor.
NCT07107633
Summary
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.
Eligibility
Inclusion Criteria: Only those who meet all the following requirements are eligible to join the group: 1. Adults over 18 years of age (based on the time when the informed consent form was signed) can be male or female; 2. Subjects with gastrointestinal malignant tumor confirmed by histology/cytology; 3. Subjects to be surgically removed or explored; 4. The estimated survival time is ≥12 weeks; 5. Subjects of childbearing age agreed to adopt effective contraceptive measures during the study period; 6. 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: 1. 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; 2. symptomatic brain metastases who need treatment; 3. Have serious cardiovascular and cerebrovascular diseases; 4. There are other contraindications for imaging examination of the research plan, such as claustrophobia; 5. Have a history of other malignant tumors; 6. Pregnant (pregnancy test positive in screening period) or lactating women; 7. Other circumstances that the researcher considers inappropriate to participate in this clinical trial.
Conditions3
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NCT07107633