RecruitingPhase 2NCT07107633

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.


Sponsor

Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.

Enrollment

90 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria15

  • 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.

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Interventions

DRUGTechnetium [99mTc]-H7ND injection

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


Locations(1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

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NCT07107633


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