Actively Recruiting
Application of 68Ga-FAPI-04 PET/CT in the Assessment of Inflammatory Activity in Sjogren's Syndrome
Led by Peking Union Medical College Hospital · Updated on 2025-12-01
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sjogren's syndrome (SS) is a chronic autoimmune disease mainly affecting the salivary and lacrimal glands, causing dryness in the mouth and eyes. It can also impact other parts of the body, leading to symptoms like fatigue and joint pain, with a risk of lymphoma in severe cases. This study aims to evaluate the use of 68Ga-FAPI PET/CT imaging to assess inflammatory activity in SS and compare the inflammation patterns with those seen in tumor patients. The goal is to better guide treatment decisions by understanding how this imaging technique reflects disease activity. Participants diagnosed with SS will receive an intravenous injection of 68Ga-FAPI, a tracer used in PET/CT scans to detect inflammation. The study includes two groups: one with SS patients undergoing 68Ga-FAPI PET/CT scans, and a control group of tumor patients also receiving the same imaging procedure. The study will measure how the tracer is taken up in affected tissues and compare uptake patterns between autoimmune inflammation and tumors. The study is non-randomized and includes adults aged 18 to 80 years. During the study, participants will undergo PET/CT scans to capture images of inflammation in the glands and other tissues. Researchers will analyze the timing of optimal imaging, correlate PET findings with inflammatory markers, and compare tracer uptake between SS and tumor groups. The study will last up to three months for imaging follow-up, with close monitoring of clinical symptoms and blood tests. This approach aims to provide new insights into disease activity and help tailor future treatments for people with SS.
CONDITIONS
Brief Title
Analyse of Inflammatory Activity of Sjögren's Syndrome on 68Ga-FAPI PET-CT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Fulfillment of the 2016 ACR-EULAR Classification Criteria for primary Sjogren's syndrome at enrollment
- Diagnosis of a solid tumor scheduled for FAPI PET imaging
You will not qualify if you...
- Presence of tumors or other connective tissue diseases in Sjogren's syndrome group
- Current use of hormones or biological agents in either group
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo 68Ga-FAPI PET/CT imaging to assess inflammatory activity in Sjögren's syndrome or to evaluate tumor lesions.
1 imaging visit
Duration - 6 weeks to 3 months
Participants are monitored for correlation with inflammatory markers and comparative analysis of FAPI uptake between Sjögren's syndrome and tumor patients.
Follow-up visits for assessments depending on clinical needs
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zhaohui Zhu, MD
J
Jiarou Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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