Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT07172503
Eligibility Criteria:
Inclusion Criteria:
Each subject must meet all enrollment criteria to be eligible to participate in the study:
* 1: The subject or his/her legal representative is able to sign and date the informed consent form;
* 2: A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
* 3: Adult patients or healthy volunteers (aged 18 or above) of either sex;
* 4: Patients with clinically suspected or confirmed malignant tumors such as colorectal cancer, gastric cancer, pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
* 5: Consistent with the results of specific laboratory tests;
* 6: Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study；
* 7: Other set entry criteria.
Exclusion Criteria:
All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
* 1: Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
* 2: Having other comorbidities;
* 3: Patients with known hypersensitivity to GPA33 nanobody developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
* 4: Have a history of comorbid drug use;
* 5: Patients considered by the investigator to have poor compliance;
* 6: Patients during pregnancy or lactation;
* 7: Persons with other factors that make participation in this test inappropriate.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07172503
Study Brief:
Protocol Section:
NCT07172503