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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT06719856
Eligibility Criteria:
Inclusion Criteria:
1. Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;
2. age ≥18 and ≤75 years old, male or female;
3. ECOG score 0 or 1;
4. expected survival time ≥6 months;
5. There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;
6. Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;
7. patients recommended by clinicians to undergo PET/CT examination for tumor staging;
8. The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.
Exclusion Criteria:
1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
2. Individuals known or suspected to be allergic to the investigational drug or any of its components.
3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \> 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) \> 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) \> 2.5 × 40 µmol/L, or serum creatinine \> 1.5 × 130 µmol/L.
4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06719856
Study Brief:
Protocol Section:
NCT06719856