Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07324733

Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

⁶⁸Ga-FAPI PET/CT

Diagnostic Test

FAPI PET imaging to assess inflammatory activity (FAPI) in patients with primary Sjögren's syndrome.

Primary outcomes

  1. Difference in Salivary Gland PSMA Uptake Across Groups

    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.

Secondary outcomes

  1. Multiglandular PSMA Uptake Comparison

    Time frame: Baseline

    Evaluation of PSMA PET uptake (SUVmax, SUVmean) in the parotid, submandibular, and lacrimal glands across the same study groups.

  2. Correlation Between PSMA Uptake and Clinical Indicators

    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.

  3. Quantitative and Spatial Relationship Between PSMA and FAPI Uptake Definition

    Time frame: Baseline

    • Quantitative correlation: Association between PSMA SUV and FAPI SUV in the same glands.
    • Spatial co-localization: Overlap or complementarity of low-PSMA and high-FAPI regions within individual glands using image fusion and voxel-based analysis (e.g., Dice coefficient).

Study contacts

Contact information is provided by the study sponsor or research team.

Jiarou Wang, MD

CONTACT

[email protected]

13628477019

Zhaohui Zhu, MD

CONTACT

[email protected]

13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

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.