NCT06416852

Clinical Study of 18F-Alfatide Injection PET/CT

A Multicenter, Open, Non-inferiority Phase III Clinical Study to Evaluate the Efficacy of 18F-Alfatide Injection PET/CT Compared With 18F-FDG PET/CT in the Diagnosis of Lymph Node Metastasis in Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open, non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer. This trial will include 428 patients with non-small cell lung cancer confirmed by imaging, histopathology and/or cytology or highly suspected by investigators, suspected lymph node metastasis and proposed radical surgery and lymph node dissection. Eligible subjects will receive 18F-Alfatide Injection PET/CT and 18F-FDG PET/CT scans within 1 week. Subjects will undergo relevant security checks before and after each scan. The subjects underwent radical surgery and lymph node dissection within 2 weeks of completing both scans, and the obtained lymph nodes were pathologically examined as the gold standard to compare the diagnostic efficacy of 18F-Alfatide versus 18F-FDG for lymph node metastasis.

Conditions

• Non-Small Cell Lung Cancer NSCLC

Interventions

Type	Name	Description
DRUG	18F-Alfatide Injection	A single dose of (0.1\~0.15）±0.015 mCi/kg IV injection of 18F-Alfatide. The patients will be intravenously injected with 18F-Alfatide Injection and undergo PET/CT scan at 60 min±10 min after the injection.
DRUG	18F-FDG Injection	A single dose of 5～10mCi IV injection of 18F-FDG. The patients will be intravenously injected with 18F-FDG Injection and undergo PET/CT scan at 40 min±10 min after the injection.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: China