68Ga-FAPI PET-CT to image inflammation in Sjögren's syndrome
Official title: Application of [68Ga]Ga-FAPI-04 PET/CT in the Assessment of Inflammatory Activity in Sjögren's Syndrome
Run by Peking Union Medical College Hospital · NCT07062523 · Data updated 2026-11-12
This trial will test whether 68Ga-FAPI PET-CT can show active inflammation in adults with Sjögren's syndrome compared with tumor patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | September 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07062523 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–80 with primary Sjögren's meeting the 2016 ACR-EULAR criteria, or patients with solid tumors already scheduled for FAPI PET-CT, who are not on hormones or biological agents and are not pregnant or lactating.
✕Probably not a fit
Patients with overlapping connective tissue diseases, current hormone or biological therapy, active cancer (for the Sjögren's group), or who are pregnant or breastfeeding may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective interventional imaging study using 68Ga-FAPI PET-CT to characterize uptake patterns in patients with primary Sjögren's syndrome and a control group of patients with solid tumors. Adults aged 18–80 who meet the 2016 ACR-EULAR criteria for primary Sjögren's or tumor patients scheduled for FAPI imaging will undergo PET-CT and quantitative analysis of glandular and extra-glandular uptake. Patients with other connective tissue diseases, concurrent tumors in the Sjögren's group, current hormone or biological therapy, or who are pregnant or breastfeeding will be excluded. Imaging findings will be compared between the groups to determine whether FAPI uptake correlates with inflammatory activity in Sjögren's syndrome and could help guide clinical management.
Why it matters
Potential benefit: If successful, FAPI PET-CT could help clinicians identify where inflammation is active in Sjögren's patients and better target treatment decisions.
How similar studies have gone: FAPI PET-CT has shown promising uptake in various inflammatory and oncologic conditions, but its specific use in Sjögren's syndrome is novel and not yet validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Peking Union Medical College Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Zhaohui Zhu, MD
- Email: 13611093752@163.com
- Phone: 13611093752
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.