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

NCT07062523 | Recruiting Phase 1

• 1 other identifier: PUMCH-FAPI-pSS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (3)

• Optimal imaging time

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

  up to 3 month

• 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.

  6 weeks

• 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.

  up to 3 months

Study Arms (2)

68Ga-FAPI PET/CT in Sjögren's Syndrome

EXPERIMENTAL

All patients diagnosed with Sjögren's syndrome underwent 68Ga-FAPI PET/CT.

Drug: 68Ga-FAPI

68Ga-FAPI PET/CT in tumor patients

EXPERIMENTAL

Patients with tumors such as lung cancer and breast cancer, who had been excluded for Sjögren's syndrome, underwent 68Ga-FAPI PET/CT.

Drug: 68Ga-FAPI

Interventions

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.

Also known as: 68Ga-Fibroblast activation protein Inhibitor

68Ga-FAPI PET/CT in Sjögren's Syndrome; 68Ga-FAPI PET/CT in tumor patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

68Ga-FAPI

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zhaohui Zhu, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

13611093752; 13611093752@163.com

Jiarou Wang, MD

CONTACT

13628477019; ChristinaWang97@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 14, 2025
• Study Start: July 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-05

Locations

CN (1)