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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: pSS Dual-Tracer Imaging Arm (PSMA + FAPI PET)Experimental treatment 2 interventions
Group B: Prostate Cancer PSMA-Only Comparator ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

Multiglandular PSMA Uptake Comparison

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

Time frame
Baseline
2

Correlation Between PSMA Uptake and Clinical Indicators

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
3

Quantitative and Spatial Relationship Between PSMA and FAPI Uptake Definition

1. Quantitative correlation: Association between PSMA SUV and FAPI SUV in the same glands. 2. 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).

Time frame
Baseline

Other outcomes

Sponsors and contacts

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