Adenocarcinoma of GE Junction, Adenocarcinoma of the Stomach, Pancreatic Cancer Stage
Conditions
Brief summary
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction
Interventions
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.
Sponsors
SmartNuclide Biopharma
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age range of 18 to 75 years old (including boundary values); * Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF); * Diagnosed G/GEJ adenocarcinoma and pancreatic cancer; * Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any); * Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).
Exclusion criteria
* Merge patients with other clearly diagnosed malignant tumors: * Uncontrolled severe infections or individuals with other serious illnesses; * Those with an expected survival period of less than or equal to three months; * Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial; * investigators determine that patients who are not suitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological distribution characteristics | 1week | 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). |
| Safety tolerance characteristics | hrough study completion, an average of 1 year | AE/SAE/SUSAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Dynamics Evaluation and Radiation Dose | 1 day | Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploring the targeting ability of CLDN18.2 | 1month | 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) |
Countries
China
Contacts
Primary ContactMiao liyan Chief Pharmacist, doctorate
Outcome results
None listed