Peking Union Medical College Hospital
Beijing, China
Location status: Recruiting
Location contact
Jiarou Wang, MD
CONTACT
Zhaohui Zhu, MD
CONTACT
NCT Number: NCT07324733
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Beijing, China
Location status: Recruiting
Jiarou Wang, MD
CONTACT
Zhaohui Zhu, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PSMA PET imaging performed for clinical evaluation in prostate cancer patients, used as a comparator for physiologic salivary gland PSMA uptake.
FAPI PET imaging to assess inflammatory activity (FAPI) in patients with primary Sjögren's syndrome.
Time frame: 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.
Time frame: Baseline
Evaluation of PSMA PET uptake (SUVmax, SUVmean) in the parotid, submandibular, and lacrimal glands across the same study groups.
Time frame: Baseline
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.
Time frame: Baseline
Contact information is provided by the study sponsor or research team.
Jiarou Wang, MD
CONTACT
Zhaohui Zhu, MD
CONTACT
Peking Union Medical College Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07246096
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
Shanghai, China
View Trial DetailsNCT03509064
Medico-economic Impact, Nervous System Diseases
Paris, France
View Trial DetailsNCT06440525
Primary Sjögren Syndrome
Chula Vista, California, United States
View Trial DetailsNCT06528197
Primary Sjögren Syndrome
Beijing, Beijing Municipality, China
View Trial Details