SAPHO Syndrome
Conditions
Brief summary
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. 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 SAPHO than 18F-FDG PET/CT.
Detailed description
Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. Inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. Owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. Therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68Ga-FAPI that targets fibroblast activation protein (FAP) is introduced in tumor imaging. However, FAP was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for SAPHO to be imaged with 68Ga-FAPI. The aim of this study is to evaluate the performance of 68Ga-FAPI PET/CT in SAPHO and to compare it with the performance of 18F-FDG PET/CT.
Interventions
DRUG68Ga-FAPI
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 SAPHO by PET/CT.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* suspected or confirmed untreated SAPHO patients; * 18F-FDG PET/CT within two weeks; * signed written consent.
Exclusion criteria
* pregnancy; * breastfeeding; * known allergy against FAPI * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic value | through study completion, an average of 1 year | Sensitivity and Specificity of 68Ga-FAPI PET/CT for SAPHO in comparison with 18F-FDG PET/CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic parameters | through study completion, an average of 1 year | Total Lesion Glycolysis (TLG) of SAPHO lesions are measured on 68Ga-FAPI PET/CT. |
| FAPI expression and SUV | through study completion, an average of 1 year | Correlation between FAPI expression and SUV in PET |
| Disease burden assessement | through study completion, an average of 1 year | Correlation between Total Lesion Glycolysis (TLG) of bone lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for SAPHO |
Countries
China
Contacts
Primary ContactPeipei Wang, MD
Backup ContactGuozhu Hou, MD
Outcome results
None listed