Technetium [99mTc]-H7ND injection to detect peritoneal metastasis in gastrointestinal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II interventional study gives a radiolabeled tracer, technetium [99mTc]-H7ND, to adults with histologically confirmed gastrointestinal malignancies who are planned for surgical removal or exploration. Participants will receive the injection prior to surgery and imaging findings will be compared to intraoperative and pathological results to determine diagnostic performance and an optimal threshold for tracer uptake. Safety outcomes and adverse events related to the radiotracer will be recorded throughout the study period. The trial aims to define both how well the tracer detects peritoneal disease and whether it is safe in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital Affiliated to Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Hongcheng Shi
• Email: shi.hongcheng@zs-hospital.sh.cn
• Phone: 021-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.