Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhaohui Zhu, MD
13611093752@163.com
13611093752
Backup
Jiarou Wang, MD
ChristinaWang97@163.com
13628477019
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
Experimental: pSS Dual-Tracer Imaging Arm (PSMA + FAPI PET)
This arm includes patients diagnosed with primary Sjögren's syndrome. All participants undergo both PSMA PET and FAPI PET imaging. The PSMA PET scan is used to assess the functional integrity of salivary gland acinar cells, while the FAPI PET scan evaluates inflammatory and fibroblast activity within the same glands. The purpose of this arm is to characterize the functional-inflammatory relationship in pSS and to develop the combined PSMA/FAPI Index for disease staging and activity assessment.
Active_comparator: Prostate Cancer PSMA-Only Comparator Arm
This arm consists of patients with prostate cancer who undergo PSMA PET imaging only, representing a population with preserved or physiologic salivary gland PSMA uptake. These scans serve as a reference group for establishing normal or baseline PSMA expression in salivary glands. This comparator arm allows differentiation between disease-related PSMA reduction in pSS and normal tracer distribution observed in patients without salivary gland pathology.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital