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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose escalation | Experimental | 4 subgroups mass dose escalation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NOTA-SNA002 | Drug | 68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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. | through study completion, an average of 1 month |
| Biological distribution characteristics | Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET | 60 minutes ~120 minutes after administration |
| Anti-SNA002 anti-antibody | By analyzing anti-SNA002 anti-drug antibody positive rate. | up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in whole blood and serum radioactive dose | Measurement of 68Ga Radiation exposure in whole blood and serum after administration | 60 minutes after Blood sampling |
| Standardized uptake values based on whole-body PET imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongcheng Shi, Doctor | Department of Nuclear Medicine, Zhongshan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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Analyzing whole body PET images,Define area of interest (ROI) and/or volume of Interest (VOI), calculate standardized uptake values (SUVmax, SUVmean, etc.)
| 1 month |
| Radiation absorbed dose of major organs | Calculation of the radiation dose for each vital organ by means of radiation uptake values | 1 month |