About this trial
Sjögren's syndrome (SS) is a chronic autoimmune disease primarily affecting the salivary and lacrimal glands, leading to symptoms of dryness. Assessing the inflammatory activity is crucial for guiding treatment. Fibroblast activation protein (FAPI) PET is an emerging imaging technique increasingly used for evaluating various inflammations and tumors. Thus this prospective study is going to investigate the uptake characteristics of FAPI PET in Sjögren's syndrome and evaluate its potential in assessing inflammatory activity to guide clinical treatment. A control group of tumor patients undergoing FAPI PET imaging will be included to compare FAPI uptake patterns between autoimmune inflammation and neoplasia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-80 years;
Fulfillment of the 2016 ACR-EULAR Classification Criteria for pSS at enrollment. OR diagnosis of a solid tumor scheduled for FAPI PET imaging
Disqualifiers
Combined with tumors or other connective tissue diseases (for SS group);
Patients who are currently using hormones/biological agents (for both groups);
Pregnancy or lactation
Trial design
Parallel
Treatments tested in this trial
68Ga-FAPI
DrugIntravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga- FAPI will be used to image lesions of Sjögren's syndrome by PET/ CT.
Treatment groups
Trial outcomes
Primary outcomes
Optimal imaging time
Patients were included for PET dynamic imaging to find the optimal imaging time for FAPI PET in Sjögren's syndrome
Correlation with inflammatory markers
Inflammatory and immune markers (e.g., IL-6, TNF-α, CRP) were measured using enzyme-linked immunosorbent assay (ELISA) in all patients, and correlational analysis was performed with PET uptake values.
Comparative uptake analysis between Sjögren's syndrome and tumor patients
Comparison of standardized uptake values (SUV) and distribution patterns of 68Ga-FAPI in salivary/lacrimal glands of SS patients versus tumor lesions in the control group.
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