NCT07062523RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Jun 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Sjögren's disease
- NCT number
- NCT07062523
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 1 Jul 2024 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are currently using hormones/biological agents (for both groups)；
Other illness
- Combined with tumors or other connective tissue diseases (for SS group);
Other
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
Related publications
- 68Ga-FAPI PET/CT for assessing fibroblast activation and disease activity in primary Sjögren's disease: a prospective case-control study.Rheumatology (Oxford) · 2026 · PMID 42663571
This page is information, not medical advice. Discuss any trial with your doctor.