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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8
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.
Precision Molecular Imaging & Theranostics (trading as Melbourne Theranostic Innovation Centre)
Melbourne, Australia
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.
Time frame: Through study completion, assessed up to 2 years
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Through study completion, assessed up to 2 years
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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).
Time frame: 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)
Time frame: Through study completion, assessed up to 2 years