Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471712
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-04
Brief Title:
Clinical Study of 18F-LNC1007 Injection PETCT
Sponsor:
Yantai LNC Biotechnology Singapore PTE LTD
Organization:
Yantai LNC Biotechnology Singapore PTE LTD
Study Overview
Official Title:
A Phase I Clinical Trial of 18F-LNC1007 Injection PETCT in Healthy Volunteers and Light Tumor Burden Patients for Evaluating Its Pharmacokinetics BiodistributionDosimetry and Safety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 study is a single-arm single-center trial aimed at evaluating the pharmacokinetics bio-distribution dosimetry and safety of 18F-LNC1007 injection in healthy volunteers and light tumor burden cancer patients as defined by 5 lesions on a conventional PETCT done for clinical purposes and molecular imaging tumor volume of 10ml
All participants must provide a signed consent form before enrolling in the trial
For each participant the study duration will be about 3 weeks including 2 weeks screening 1 week of scanning and safety follow-up
All participants must provide a signed consent form before enrolling in the trial
For each participant the study duration will be about 3 weeks including 2 weeks screening 1 week of scanning and safety follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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