Clinical Study of 18F-Alfatide Injection PET/CT

Non-Small Cell Lung Cancer NSCLC Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06416852
Study type	Interventional
Source	Yantai LNC Biotechnology Singapore PTE. LTD.
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Status	Not yet recruiting
Phase	Phase 3
Start date	August 2024
Completion date	December 2026

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