Suspected rheumatoid arthritis
Conditions
Interventions
Gold Standard:Diagnosis is made using the classification criteria for rheumatoid arthritis (RA) jointly issued by the American College of Rheumatology (ACR) and the European League Against Rheumatism
Index test:[18F]AlF-FAPI42-RGD PET/CT imaging
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participate in this trial and sign the informed consent form. 2.Aged>= 18 years and <= 80 years (based on the date of signing the informed consent form), with no restriction on gender. 3.Patients with suspected rheumatoid arthritis who are scheduled to undergo synovial biopsy for pathological confirmation. 4.The subjects obtained pathological results within two weeks after undergoing [18F]AlF-FAPI-RGD PET/CT imaging. 5.Physical fitness status score: 0~1 point. 6.The expected survival time is more than 12 months. 7.Female subjects of childbearing age, male subjects, or the partners of male subjects agree to use reliable contraceptive methods (such as abstinence, sterilization, contraceptives, injectable contraceptive medroxyprogesterone, or subcutaneous implant contraception, etc.) within 6 months after the end of the last study drug infusion. 8.Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1.Any history of other rheumatoid arthritis within the past 5 years. 2.Previous use of radionuclides with an interval of less than 10 physical half-lives from the time of drug administration in this study. 3.Currently participating in or planning to participate in any drug or device clinical trial during the study period. 4.Unable to lie flat or remain still during a PET scan, or intolerant of a PET scan. 5.Those with a history of fractures or anemia in the past year. 6.Subjects with abnormalities in physical examination, ECG, and clinical laboratory tests during the screening period, which, as determined by the investigator, may affect safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specificity;Accuracy rate;Sensitivity; | — |
Countries
China
Contacts
Public ContactDong Mengjie
Peking University Shenzhen Hospital
Outcome results
None listed