Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416852
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
Clinical Study of 18F-Alfatide Injection PETCT
Sponsor:
Yantai LNC Biotechnology Singapore PTE LTD
Organization:
Yantai LNC Biotechnology Singapore PTE LTD
Study Overview
Official Title:
A Multicenter Open Non-inferiority Phase III Clinical Study to Evaluate the Efficacy of 18F-Alfatide Injection PETCT Compared With 18F-FDG PETCT in the Diagnosis of Lymph Node Metastasis in Non-small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter open non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PETCT compared with 18F-FDG PETCT 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 andor 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 PETCT and 18F-FDG PETCT 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
This trial will include 428 patients with non-small cell lung cancer confirmed by imaging histopathology andor 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 PETCT and 18F-FDG PETCT 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None