The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial, 68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation absorption dose, distribution characteristics, etc. in patients with solid tumors.
The study consisted of four phases: screening period , baseline period , trial period and safety follow-up period . Screening period 2 weeks before the start of the trial, all eligible subjects were selected to participate in the clinical trial. The informed consent signed by the subjects is required before performing all the examinations in this clinical trial. Baseline period The admission criteria were checked again, and the subjects were enrolled on the same day after the check. Trial period Including drug administration, blood collection, image collection and pathological tissue collection. Safe follow-up period All adverse events and drug combinations are processed and recorded during this period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
17
68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
Safety of administration(Vital signs)
The safety of administration will be evaluated based on the assessments of blood pressure, heart rate, respiration and body temperature before and after administration(% of cases with abnormal findings relative to baseline).
Time frame: up to 7 days
Laboratory examination
such as blood routine, blood biochemistry, urine routine, coagulation function, etc., to evaluate the changes of laboratory examination of subjects before and after administration
Time frame: up to 7 days
Incidence of adverse events
The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of 68Ga-NOTA-SNA002.
Time frame: through study completion, an average of 1 month
Biological distribution characteristics
Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET
Time frame: 60 minutes ~120 minutes after administration
Anti-SNA002 anti-antibody
By analyzing anti-SNA002 anti-drug antibody positive rate.
Time frame: up to 1 month
Changes in whole blood and serum radioactive dose
Measurement of 68Ga Radiation exposure in whole blood and serum after administration
Time frame: 60 minutes after Blood sampling
Standardized uptake values based on whole-body PET imaging
Analyzing whole body PET images,Define area of interest (ROI) and/or volume of Interest (VOI), calculate standardized uptake values (SUVmax, SUVmean, etc.)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 month
Radiation absorbed dose of major organs
Calculation of the radiation dose for each vital organ by means of radiation uptake values
Time frame: 1 month