Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
28 participants
INTERVENTIONAL
2024-10-20
2025-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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dose escalation
subgroups mass does escalation
[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.
Interventions
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[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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
75 Years
ALL
No
Sponsors
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SmartNuclide Biopharma
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University
Jiangsu, Province, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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[68Ga]Ga-NODAGA-SNA014
Identifier Type: -
Identifier Source: org_study_id
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