Clinical Trial · 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.

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Hongcheng Shi (CONTACT)

shi.hongcheng@zs-hospital.sh.cn

021-64041990

ClinicalTrials.gov

NCT07107633

Drug / Compound

H7ND

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: HYNIC
Linker: PEG4

Eligibility

Inclusion

  • Only those who meet all the following requirements are eligible to join the group:
  • Subjects with gastrointestinal malignant tumor confirmed by histology/cytology;
  • Subjects to be surgically removed or explored;
  • symptomatic brain metastases who need treatment;
  • Pregnant (pregnancy test positive in screening period) or lactating women;
  • Have a history of other malignant tumors;
  • Have serious cardiovascular and cerebrovascular diseases;
  • There are other contraindications for imaging examination of the research plan, such as claustrophobia;
  • The estimated survival time is ≥12 weeks;
  • 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;
  • Other circumstances that the researcher considers inappropriate to participate in this clinical trial.

Exclusion

Exclusion criteria not yet provided.