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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Technetium [99mTc]-H7ND injection.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Peritoneal Metastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- Drug Technetium [99mTc]-H7ND injection
Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor
Primary outcome measures
- To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor [Time frame: 1-7 days from time of injection]
Eligibility criteria
Inclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Zhongshan Hospital Affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT07107633 · 2025-024R