RecruitingNot ApplicableNCT07324733

Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging


Sponsor

Peking Union Medical College Hospital

Enrollment

60 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Primary Sjögren's syndrome (pSS) is a chronic autoimmune exocrinopathy characterized by lymphocytic infiltration, progressive destruction of salivary gland acini, and varying degrees of functional impairment and fibrosis. Conventional imaging provides limited ability to simultaneously evaluate glandular function and inflammatory activity, leading to challenges in disease staging and treatment decision-making. This study explores a conceptual dual-tracer imaging framework using PSMA PET and FAPI PET to delineate complementary biological processes in pSS.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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 Criteria3

  • 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

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Interventions

DIAGNOSTIC_TEST⁶⁸Ga-PSMA PET/CT

PSMA PET imaging performed for clinical evaluation in prostate cancer patients, used as a comparator for physiologic salivary gland PSMA uptake.

DIAGNOSTIC_TEST⁶⁸Ga-FAPI PET/CT

FAPI PET imaging to assess inflammatory activity (FAPI) in patients with primary Sjögren's syndrome.


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT07324733


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