Phase II Study of Technetium 99mTc-H7ND Injection to Diagnose Peritoneal Spread in Gastrointestinal Cancers

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.

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.