NCT07107633 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.
| NCT ID | NCT07107633 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-03-12 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07107633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07107633 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07107633 currently recruiting?
Yes, NCT07107633 is actively recruiting participants. Contact the research team at shi.hongcheng@zs-hospital.sh.cn for enrollment information.
Where is the NCT07107633 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07107633 clinical trial?
NCT07107633 is sponsored by Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.. The trial plans to enroll 90 participants.