Patients with suspected malignant tumors
Conditions
Interventions
Gold Standard:The pathological result is the gold standard
Index test:18F-FAPI PET/CT imaging
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study and has signed the informed consent form; 2. Age >= 18 years and <= 80 years (based on the date of signing the informed consent form), regardless of gender; 3. Patients suspected of having malignant tumors but without confirmed pathological results; 4. Subjects obtain pathological results within two weeks after undergoing 18F-FAPI PET/CT imaging; 5. Performance status score of 0–1; 6. Expected survival time longer than 12 months; 7. Female subjects of childbearing potential, male subjects, and female partners of male subjects agree to use reliable contraception (e.g., abstinence, sterilization, oral contraceptives, depot medroxyprogesterone acetate, or subdermal contraceptive implants) for 6 months after the last infusion of study drug; 8. Willing and able to comply with scheduled visits, diagnostic procedures, clinical laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1.Have a history of any other malignant tumors within the past 5 years; 2.Previously used radioactive nuclides and the time interval from the administration of this study is less than 10 physical half - lives; 3.Currently participating or planning to participate in any drug or device clinical trials during the research period; 4.Unable to lie flat or remain still during a PET scan, or intolerant of PET scans; 5.Those with a history of fracture or anemia in the past 1 year; 6.Subjects with abnormalities in physical examinations, ECG, and clinical laboratory tests during the screening period, who, as determined by the investigator, may affect safety or compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Accuracy rate; | — |
Countries
China
Contacts
Public ContactDong Mengjie
Peking University Shenzhen Hospital
Outcome results
None listed