drugset / Trial / NCT07062523

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

NCT07062523

Phase 1/2 Recruiting 60 enrolled Peking Union Medical College Hospital
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2024-07-01
Primary completion
2025-09-01
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject FAPI GA-68 Diagnostic / imaging agent 18.5 mbq/kg Intravenous
Subject FAPI GA-68 Diagnostic / imaging agent 22.2 mbq/kg Intravenous

Indications