NCT07062523 Analyse of Inflammatory Activity of Sjögren's Syndrome on 68Ga-FAPI PET-CT
| NCT ID | NCT07062523 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Sjogren's Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-07-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Zhaohui Zhu, MD
STUDY CHAIR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT07062523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sjogren's Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07062523 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07062523 currently recruiting?
Yes, NCT07062523 is actively recruiting participants. Contact the research team at 13611093752@163.com for enrollment information.
Where is the NCT07062523 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07062523 clinical trial?
NCT07062523 is sponsored by Peking Union Medical College Hospital. The principal investigator is Zhaohui Zhu, MD at Peking Union Medical College Hospital. The trial plans to enroll 60 participants.