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68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease and inflammatory bowel disease. Some researches identified FAP expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients.Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of arthritis than 18F-FDG PET/CT.
Arthritis is a term used to mean any disorder that affects the joints. The two most common forms of arthritis are osteoarthritis and rheumatoid arthritis.Rheumatoid arthritis is an autoimmune chronic inflammatory disease of unknown etiology and is characterized by chronic inflammation of the joint capsule's synovial membrane. This chronic inflammation ultimately destroys the underlying cartilage and bone. Activated fibroblast-like synoviocytes (FLS) line the synovial membrane and are a prominent cell type responsible for inflammation and joint destruction. Osteoarthritis is characterized by degradation of joint cartilage. Studies demonstrate chondrocytes expressed FAP and that chondrocyte FAP expression was elevated in patients with osteoarthritis. Other researches identified FAP expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients. However, FAP expression was greater in samples taken from refractory rheumatoid arthritis patients in comparison to end-stage osteoarthritis patients.68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease and inflammatory bowel disease. Recently the investigators have published an article of the application of 68Ga-FAPI in IgG4-related disease which showed it was more sensitive than FDG in detecting a certain type of inflammations. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of arthritis than 18F-FDG PET/CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-FAPI, PET/CT | Experimental | Inject 68Ga-FAPI and then perform PET/CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI | Drug | Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of arthritis by PET/CT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value | Sensitivity and Specificity of 68Ga-FAPI PET/CT for IgG4-RD in comparison with 18F-FDG PET/CT. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic parameters | Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT. | Time Frame: through study completion, an average of 1 year |
| Disease burden assessement | whether Total Lesion Glycolysis (TLG) assessed on 68Ga-FAPI PET/CT was correlated with clinical parameters for arthritis using correlation coefficients analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaping Luo, MD | Contact | 86-10-69155513 | luoyaping@live.com | |
| Qingqing Pan, MD | Contact | 86-10-69155513 | pqqelvay@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaping Luo, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40293620 | Derived | Yang D, Chen J, He G, Zhou Z, Xu J, Peng Y, Shen X, Jiang X, Pan Q, Zhao L, Fei Y, Luo Y, Yang H. Comparisons of [68 Ga]Ga-FAPI-04 PET/CT with X-ray imaging in the assessment of patients with rheumatoid arthritis. Clin Rheumatol. 2025 Jun;44(6):2191-2199. doi: 10.1007/s10067-025-07414-y. Epub 2025 Apr 28. | |
| 38175339 | Derived |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000707753 | 68Ga-FAPI |
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|
| through study completion, an average of 1 year |
| FAPI expression and SUV | Correlation between FAPI expression and SUV in PET | through study completion, an average of 1 year |
| Therapy response | Change of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy | through study completion, an average of 1 year |
| Pan Q, Yang H, Zhou Z, Li M, Jiang X, Li F, Luo Y, Li M. [68 Ga]Ga-FAPI-04 PET/CT may be a predictor for early treatment response in rheumatoid arthritis. EJNMMI Res. 2024 Jan 4;14(1):2. doi: 10.1186/s13550-023-01064-4. |