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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Application of [68Ga]Ga-FAPI-04 PET/CT in the Assessment of Inflammatory Activity in Sjögren's Syndrome

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments Being Tested

DRUG

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.

Locations (1)

Peking Union Medical College Hospital
Beijing, China