NCT06471712

Clinical Study of 18F-LNC1007 Injection PET/CT

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Cancer Patients

Interventions

Type	Name	Description
DRUG	18F-LNC1007 Injection	Healthy volunteers will receive 1 MBq/kg and cancer patients will receive 3.7 MBq/kg. The injection will be carried out on the scan bed via an IV indwelling catheter. A 10 mL normal saline flush will be given after the completion of the injection to ensure the residue is injected.

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-03-02
• Completion: 2025-03-02
• First posted: 2024-06-24
• Last updated: 2025-09-08

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study