Analyse of Inflammatory Activity of Sjögren's Syndrome on 68Ga-FAPI PET-CT

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

Sjögren's syndrome (SS) is a chronic autoimmune disease primarily affecting the salivary and lacrimal glands, leading to symptoms of dryness. Assessing the inflammatory activity is crucial for guiding treatment. Fibroblast activation protein (FAPI) PET is an emerging imaging technique increasingly used for evaluating various inflammations and tumors. Thus this prospective study is going to investigate the uptake characteristics of FAPI PET in Sjögren's syndrome and evaluate its potential in assessing inflammatory activity to guide clinical treatment. A control group of tumor patients undergoing FAPI PET imaging will be included to compare FAPI uptake patterns between autoimmune inflammation and neoplasia.

Eligibility criteria

This trial accepts 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-FAPI

    Drug

    Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga- FAPI will be used to image lesions of Sjögren's syndrome by PET/ CT.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: 68Ga-FAPI PET/CT in Sjögren's SyndromeExperimental treatment 1 intervention
Group B: 68Ga-FAPI PET/CT in tumor patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Optimal imaging time

Patients were included for PET dynamic imaging to find the optimal imaging time for FAPI PET in Sjögren's syndrome

Time frame
up to 3 month
2

Correlation with inflammatory markers

Inflammatory and immune markers (e.g., IL-6, TNF-α, CRP) were measured using enzyme-linked immunosorbent assay (ELISA) in all patients, and correlational analysis was performed with PET uptake values.

Time frame
6 weeks
3

Comparative uptake analysis between Sjögren's syndrome and tumor patients

Comparison of standardized uptake values (SUV) and distribution patterns of 68Ga-FAPI in salivary/lacrimal glands of SS patients versus tumor lesions in the control group.

Time frame
up to 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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