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

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-09-30

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.

Conditions

Solid Tumor; Peritoneal Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with malignant tumors of the gastrointestinal tract

Group Type: EXPERIMENTAL

Technetium [99mTc]-H7ND injection

Intervention Type: DRUG

Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor

Interventions

Technetium [99mTc]-H7ND injection

Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongcheng Shi

Role: CONTACT

shi.hongcheng@zs-hospital.sh.cn

021-64041990

Facility Contacts

Hongcheng Shi

Role: primary

shi.hongcheng@zs-hospital.sh.cn

021-64041990

Other Identifiers

2025-024R

Identifier Type: -

Identifier Source: org_study_id