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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pSS Dual-Tracer Imaging Arm (PSMA + FAPI PET) | Experimental | 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. |
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| Prostate Cancer PSMA-Only Comparator Arm | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ⁶⁸Ga-PSMA PET/CT | Diagnostic Test | PSMA PET imaging performed for clinical evaluation in prostate cancer patients, used as a comparator for physiologic salivary gland PSMA uptake. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Salivary Gland PSMA Uptake Across Groups | Quantitative comparison of PSMA PET uptake parameters (SUVmax, SUVmean) of the parotid glands among three groups: pSS patients, individuals with normal salivary glands, and prostate cancer patients. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Multiglandular PSMA Uptake Comparison | Evaluation of PSMA PET uptake (SUVmax, SUVmean) in the parotid, submandibular, and lacrimal glands across the same study groups. | Baseline |
| Correlation Between PSMA Uptake and Clinical Indicators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Zhu, MD | Contact | 13611093752 | 13611093752@163.com | |
| Jiarou Wang, MD | Contact | 13628477019 | ChristinaWang97@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| ⁶⁸Ga-FAPI PET/CT | Diagnostic Test | FAPI PET imaging to assess inflammatory activity (FAPI) in patients with primary Sjögren's syndrome. |
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Correlation of salivary gland PSMA SUV values with clinical, immunological, and functional markers of pSS, including ESR, CRP, IgG, RF, anti-SSA/SSB titers, unstimulated whole salivary flow rate, sialography findings, ESSDAI, and ESSPRI scores.
| Baseline |
| Quantitative and Spatial Relationship Between PSMA and FAPI Uptake Definition |
| Baseline |