Actively Recruiting
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
Led by Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. · Updated on 2025-08-06
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating technetium [99mTc]-H7ND injection, a radiolabeled fibroblast activation protein inhibitor, to diagnose peritoneal metastasis in patients with gastrointestinal malignant tumors. This phase II clinical study aims to assess both the safety and effectiveness of this injection, while also exploring the diagnostic threshold for detecting peritoneal metastasis in this patient group. Participants will receive technetium [99mTc]-H7ND injection during a surgical removal or exploratory procedure. The study monitors patients from 1 to 7 days after the injection to evaluate the diagnostic accuracy and safety of the agent. This is an open-access, self-controlled study conducted across multiple centers. During the study, patients will be closely observed for any adverse reactions and diagnostic outcomes. The primary outcome measure is the effectiveness of the injection in diagnosing peritoneal metastasis within 1 to 7 days following administration. Participants must comply with study requirements, including follow-up assessments and safety monitoring, until the study concludes in September 2025.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years of age (at the time of signing informed consent), male or female
- Confirmed gastrointestinal malignant tumor by histology or cytology
- Scheduled for surgical removal or exploration
- Estimated survival time of 12 weeks or more
- Willing to use effective contraceptive measures if of childbearing age during the study
- Fully understand the study purpose, methods, possible side effects, and voluntarily consent to participate and comply with study requirements
You will not qualify if you...
- Receiving treatment for digestive tract tumor during the screening period as judged by the researcher
- Symptomatic brain metastases requiring treatment
- Serious cardiovascular or cerebrovascular diseases
- Contraindications to imaging examinations such as claustrophobia
- History of other malignant tumors
- Pregnant or breastfeeding women
- Other conditions deemed inappropriate for participation by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 7 days
Participants receive a Technetium [99mTc]-H7ND injection to assist in diagnosing peritoneal metastasis of gastrointestinal malignant tumors.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
Actively Recruiting
Research Team
H
Hongcheng Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here