Patients with suspected malignant tumors not diagnosed by other methods
Conditions
Interventions
Index test:68Ga-FAPI-RGD PET/CT or 18F-AlF-FAPI-RGD PET/CT imaging
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Subjects volunteered to participate in this trial and signed an informed consent form. 2) Age >=18 years and <=80 years (based on the date of signing the informed consent form), gender is not limited. 3) Patients with suspected malignant tumors but without pathology results. 4) Pathologic results were obtained within two weeks after subjects underwent 68Ga-FAPI-RGD PET/CT or 18F-AlF-FAPI-RGD PET/CT imaging. 5) Physical fitness score 0 to 1. 6) Expected survival time is more than 12 months. 7) Female subjects of childbearing potential, male subjects, or partners of male subjects agree to use reliable contraception (e.g., abstinence, sterilization, birth control pills, injectable contraceptive megestrol, or subdermal contraception) for 6 months after the end of the final study drug infusion. 8) Willingness and ability to comply with scheduled visits, diagnostic plans, clinical laboratory tests and other test procedures.
Exclusion criteria
Exclusion criteria: 1) History of any other malignancy within the last 5 years. 2) Prior radionuclide use with an interval of less than 10 physical half-lives from the time of administration in this study. 3) Is conducting or planning to participate in any drug or device clinical trial during the study period. 4) Cannot lie flat or remain still while a PET scan is performed or does not tolerate PET scans. 5) Those with a history of fracture and anemia in the previous 1 year. 6) Subjects with abnormalities in physical examination, ECG, and clinical laboratory tests during the Screening Period that, in the judgment of the Investigator, may compromise safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor SUV value; | — |
Countries
China
Contacts
Public ContactDong Mengjie
Peking University Shenzhen Hospital
Outcome results
None listed