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.
Recruiting now · Phase 2
Conditions studied: Solid Tumor, Peritoneal Metastasis
In brief
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.
Key facts
- Study ID
- NCT07107633
- Run by
- Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.
- People needed
- 90
- Starts
- 2025-03-12
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Zhongshan Hospital Affiliated to Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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