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NCT Number: 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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Hongcheng Shi

CONTACT

[email protected]

021-64041990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Technetium [99mTc]-H7ND injection

Drug

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

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongcheng Shi

CONTACT

[email protected]

021-64041990

Sponsors and collaborators

Lead sponsor

Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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