68Ga-FAPI PET-CT to image inflammation in Sjögren's syndrome

Application of [68Ga]Ga-FAPI-04 PET/CT in the Assessment of Inflammatory Activity in Sjögren's Syndrome

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
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07062523 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Zhaohui Zhu, MD

Conditions: Sjogren's Syndrome