An Early Phase 1 interventional study of [68Ga]Ga-NODAGA-SNA014 in Adenocarcinoma of the Stomach, Adenocarcinoma of GE Junction and Pancreatic Cancer Stage, sponsored by SmartNuclide Biopharma. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by SmartNuclide Biopharma · Early Phase 1, Interventional, and Diagnostic
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's planned enrollment of 28 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →SmartNuclide Biopharma is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
subgroups mass does escalation
Drug: [68Ga]Ga-NODAGA-SNA014
Perform whole-body PET/CT scans on the subjects at 30 minutes (± 5 minutes), 60 minutes (± 10 minutes), 120 minutes (± 20 minutes), and 240 minutes (± 30 minutes) after administration. Among them, PET scanning can be performed on 1-2 subjects in a certain dose group or each dose group for 30-60 minutes. Among the four CT scans, one CT scan is a conventional low-dose CT scan (120mA), and the remaining three are extremely low-dose CT scans (10-20mA). The main researchers and nuclear medicine physicians can decide whether to change the subsequent image acquisition time and duration of the subjects based on the image information obtained from the enrolled subjects.
Biological distribution characteristics
Evaluate the biological distribution characteristics of important organs in the subjects. * Draw the Volume of Interest (VOI) of the subject's vital organs and calculate the Percentage of Injected Activity (IA) of the vital organs * Using PMOD software, manually draw regions of interest (VOI) on PET/CT images of the liver, spleen, normal stomach, heart, bone marrow, kidneys, and other areas to obtain the cumulative radioactive activity of these regions. Divide the cumulative radioactive activity by the injection dose to obtain the percentage of injection activity (% IA).
Time frame: 1week
Safety tolerance characteristics
AE/SAE/SUSAR
Time frame: hrough study completion, an average of 1 year
Metabolic Dynamics Evaluation and Radiation Dose
Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs
Time frame: 1 day
Exploring the targeting ability of CLDN18.2
Correlation analysis between PET/CT imaging features of target lesions (SUVmax, SUV mean, target to body ratio, etc.) and CLDN18.2IHC expression level (if any)
Time frame: 1month
Plan to share: Yes
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