Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

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 typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment60 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedOctober 1, 2023
Main results expectedJanuary 30, 2026
Study endsSeptember 30, 2026
Registry record updatedJuly 29, 2026
Trial IDNCT07324733 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.