Using PSMA and FAPI PET scans to map salivary gland function and inflammation in Sjögren's syndrome
Official title: Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
Run by Peking Union Medical College Hospital · NCT07324733 · Data updated 2026-11-12
This study will test whether combining PSMA and FAPI PET scans can better show salivary gland function and inflammation in people with primary Sjögren's syndrome.
Quick facts
| 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 | October 1, 2023 |
| Main results expected | January 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07324733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 who meet the 2016 ACR–EULAR criteria for primary Sjögren's syndrome (or patients with a solid tumor already scheduled for FAPI PET) and who are not using hormones or biological agents are ideal candidates.
✕Probably not a fit
Patients with overlapping connective tissue diseases, current use of hormones or biologic therapies, pregnancy or lactation, or other contraindications to PET/CT are unlikely to receive 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 single-center study will perform paired 68Ga-PSMA PET/CT and 68Ga-FAPI PET/CT scans in adults with primary Sjögren's syndrome and a comparison group of patients scheduled for FAPI imaging for solid tumors. PSMA uptake is expected to reflect salivary acinar cell function while FAPI uptake highlights activated fibroblasts and fibroblast-driven remodeling; the investigators will compare tracer signals within the same glands. They will derive a combined PSMA/FAPI Index to map a function–inflammation spectrum and examine correlations between the two tracers and clinical disease features. Imaging results will be analyzed to explore whether this noninvasive paired biomarker can improve staging and monitoring of pSS.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive imaging marker to more precisely stage disease, monitor progression, and help guide treatment decisions in primary Sjögren's syndrome.
How similar studies have gone: Prior imaging work has shown PSMA relates to salivary acinar cells and FAPI to fibroblast activity, but applying a paired PSMA/FAPI index in pSS is a novel and largely untested approach.
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.