Ignite Creation Date:
2025-12-18 @ 8:29 AM
Ignite Modification Date:
2025-12-18 @ 8:29 AM
Study NCT ID:
NCT06471712
Status:
None
Last Update Posted:
2025-09-08 00:00:00
First Post:
2024-06-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of 18F-LNC1007 Injection PET/CT
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase I Clinical Trial of 18F-LNC1007 Injection PET/CT in Healthy Volunteers and Light Tumor Burden Patients for Evaluating Its Pharmacokinetics, Biodistribution,Dosimetry and Safety
Status:
None
Status Verified Date:
2025-09
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 PET/CT 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: