Analyse of Inflammatory Activity of Sjögren's Syndrome on 68Ga-FAPI PET-CT

Condition(s) studied

Investigational drug(s) / intervention(s)

68Ga-FAPI: Intravenous 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.

Study summary

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

Primary outcome measure(s)

• Optimal imaging time — up to 3 month
  Patients were included for PET dynamic imaging to find the optimal imaging time for FAPI PET in Sjögren's syndrome
• Correlation with inflammatory markers — 6 weeks
  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 — up to 3 months
  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.

Trial sites (1)

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