RecruitingPhase 1Phase 2NCT07062523

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

Application of [68Ga]Ga-FAPI-04 PET/CT in the Assessment of Inflammatory Activity in Sjögren's Syndrome


Sponsor

Peking Union Medical College Hospital

Enrollment

60 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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 Criteria3

  • 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

Interventions

DRUG68Ga-FAPI

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.


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT07062523


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