Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 9:53 AM
Study NCT ID:
NCT07324733
Status:
RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Based on current evidence, salivary gland acinar cells physiologically express PSMA; thus, reduced PSMA uptake may reflect loss of functional parenchyma in patients with pSS. In contrast, activated fibroblasts markedly express FAP, and increased FAPI uptake correlates with ongoing inflammation and fibroblast-driven remodeling. We hypothesize that within the same gland, functional decline (PSMA↓) and inflammatory activity (FAPI↑) may coexist and exhibit a negative correlation, forming a paired imaging biomarker that captures both pathological dimensions. By integrating these two signals into a combined PSMA/FAPI Index, this approach may enable more precise characterization of the "function-inflammation" spectrum in pSS, providing a noninvasive tool for disease staging, monitoring, and potentially predicting therapeutic response.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: