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

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.

This trial will test whether a technetium [99mTc]-H7ND injection can help detect peritoneal metastases in adults with confirmed gastrointestinal cancers who are scheduled for surgical exploration.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07107633 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed gastrointestinal malignancy who are scheduled for surgical exploration or resection and can provide informed consent are the intended candidates.

Not a fit: Patients who are not surgical candidates, have non-gastrointestinal primary tumors, are pregnant, or cannot receive a radiotracer are unlikely to benefit from this diagnostic approach.

Why it matters

Potential benefit: If successful, the tracer could improve detection of peritoneal metastases and help guide surgical decision-making and staging for patients with gastrointestinal cancer.

How similar studies have performed: Related radiotracer imaging approaches for peritoneal disease have shown mixed results in prior work, and the specific 99mTc-H7ND tracer appears to be a novel agent with limited prior clinical data.

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.

Where this trial is running

Shanghai

• Zhongshan Hospital Affiliated to Fudan University — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Hongcheng Shi

Conditions: Solid Tumor, Peritoneal Metastasis