Clinical trial · Interventional
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.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Metastasis | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Technetium [99mTc]-H7ND injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with malignant tumors of the gastrointestinal tract
- interventionNames
- Drug: Technetium [99mTc]-H7ND injection
Primary outcomes (1)
- measure
- To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor
- timeFrame
- 1-7 days from time of injection
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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