XCancer

Clinical Study of 18F-Alfatide Injection PET/CT

Description:

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.

Sponsor:

Yantai LNC Biotechnology Singapore PTE LTD

Phase:

Phase 3

Government Study Link:

NCT06416852 - Click here to see study on

ClinicalTrials.gov

Alfatide

Isotope(s):
Target(s):
  • αvβ3
Ligand Class: Peptides

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules
Inclusion
  • Patients with non-small cell lung cancer confirmed or highly suspected by investigators based on prior history, imaging, histopathology, and/or cytology, suspected lymph node metastasis and proposed radical surgery and lymph node dissection;
  • Expected survival \> 3 months.
  • 1. The subjects understand the clinical trial procedure and sign the informed consent in person;
  • Over 18 years old (including 18 years old);
  • ECOG function status score 0\~1 points ;
Exclusion
  • Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history);
  • Patients with renal insufficiency were defined as the standard endogenous creatinine clearance (Ccr) estimated by the Cockcroft-Gault formula \<60 ml/min, Ccr(ml/min)=\[(140-age)× body weight (kg)\]/\[72×Scr(mg/dl)\], and the calculated result for females was 0.85;
  • Workers who need to be exposed to radioactive conditions for a long time;
  • 1. Known allergic history to 18F-Alfatide Injection and 18F-FDG injection or its excipients;
  • Patients who are not suitable for PET or cannot complete PET or other imaging tests due to special reasons, including claustrophobia and radiophobia;