RecruitingPhase 1Phase 2NCT07062523

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

Sponsor

Peking Union Medical College Hospital

Enrollment

60 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Sjogren's Syndrome

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of PET/CT imaging (called FAPI PET-CT) to measure inflammation and disease activity in people with Sjögren's syndrome — an autoimmune condition causing dry eyes and mouth — and compare it with imaging done in cancer patients, to better understand how this scan can be used in autoimmune disease. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with primary Sjögren's syndrome according to established criteria, OR you have a solid tumor and are already scheduled to undergo FAPI PET imaging as part of your cancer care **You may NOT be eligible if...** - You have Sjögren's syndrome AND also have a solid tumor or another connective tissue disease - You are currently taking hormone therapy or biological treatments (for either group) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-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.