Clinical Study of 18F-LNC1007 Injection PET/CT
NCT Number: NCT06471712
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers|Cancer Patients
Interventions: DRUG: 18F-LNC1007 Injection
Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2024-09
Locations: Precision Molecular Imaging & Theranostics (trading as Melbourne Theranostic Innovation Centre), Melbourne, Australia

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.

Primary Outcome Measures: Evaluate the safety of 18F-LNC1007 injection, The safety assessments of this phase I trial are based on systemic safety evaluation. The frequency and severity of Treatment emergent adverse events (TEAE) will be classified according to Common Toxicity Criteria for Adverse Events 5.0. The seriousness and relationship of study treatment will be assessed., Through study completion, assessed up to 2 years
Secondary Outcome Measures: Evaluate the radioactivity of 18F-LNC1007 injection, Patient blood samples wil be collected at 5 min , 10min , 30 min , 60 min , 120 min , 180 min , 240 min after the administration of 18F-LNC1007 Injection Patient urine samples at 0-1.5 h, 1.5-3 h and 3-4 h after the administration of 18F-LNC1007.

All samples will be drawn for radioactivity by a gamma counter., Through study completion, assessed up to 2 years|Evaluate the metabolites of 18F-LNC1007 injection, Patient blood samples wil be collected at 5 min , 30 min , 60 min , 120 min , 180 min , 240 min after the administration of 18F-LNC1007 Injection Patient urine samples at 0-1.5 h, 1.5-3 h and 3-4 h after the administration of 18F-LNC1007.

The major metabolites will be conducted by radioHPLC., Through study completion, assessed up to 2 years|Evaluate total source organ counts of 18F-LNC1007 injection, Total source organ counts based on an individualized VOI template, Through study completion, assessed up to 2 years|Evaluate the SUV values of 18F-LNC1007 Injection, The SUV values (SUVmax, SUVmean) of each organ will be summarized to reflect the biodistribution of 18F-LNC 1007 Injection in the human body., Through study completion, assessed up to 2 years|Evaluate the image quality of 18F-LNC1007 injection, The imaging variables include scoring of overall quality using Likert 5-point scale and scoring of the noise (coefficient of variance in liver)., Through study completion, assessed up to 2 years|Evaluate the effective dose of 18F-LNC1007 injection, Effective absorbed dose of the major organs (mSv/MBq) and total body effective dose (mSv/MBq), Through study completion, assessed up to 2 years