Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in Salivary Gland PSMA Uptake Across Groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ⁶⁸Ga-PSMA PET/CT (Diagnostic Test)
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.
干预措施: ⁶⁸Ga-FAPI PET/CT (Diagnostic Test)
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.
干预措施: ⁶⁸Ga-PSMA PET/CT (Diagnostic Test)
结局指标
主要结局
Difference in Salivary Gland PSMA Uptake Across Groups
时间窗: Baseline
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.
次要结局
- Multiglandular PSMA Uptake Comparison(Baseline)
- Correlation Between PSMA Uptake and Clinical Indicators(Baseline)
- Quantitative and Spatial Relationship Between PSMA and FAPI Uptake Definition(Baseline)