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NCT Number: NCT07062523

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

Sjögren's syndrome (SS), characterized by its chronic autoimmune nature, predominantly targets the salivary and lacrimal glands, resulting in the classic symptoms of dry mouth and dry eyes. This condition can extend beyond these glands, impacting other systems in the body and leading to a variety of clinical manifestations, such as fatigue, joint pain, and in more severe cases, an increased risk of lymphoma. The heterogeneity of SS, with its potential to affect multiple organs, underscores the importance of accurately assessing the level of inflammation when developing a treatment plan.

Fibroblast activation protein (FAPI) PET imaging is a cutting-edge diagnostic tool that has shown promise in the detection and evaluation of inflammation associated with a range of pathologies, including various tumors. This innovative imaging technique takes advantage of the elevated levels of FAPI, a protein that is overexpressed in cancer-associated fibroblasts, which are a common feature in numerous malignant solid tumors. Moreover, FAPI's role in inflammation suggests its potential as a biomarker for disease activity in conditions like SS.

The prospective study mentioned aims to delve deeper into the utility of FAPI PET in the context of SS. It will explore how FAPI PET imaging can be applied to visualize and quantify inflammatory changes within the salivary and lacrimal glands, which are typically affected in SS. The study will involve a cohort of SS patients who will undergo FAPI PET scans, and the findings will be correlated with their clinical symptoms, serological markers of inflammation, and other imaging modalities.

The primary objective of this study is to determine the uptake characteristics of FAPI PET in patients with SS, providing valuable data on the distribution and intensity of FAPI uptake in affected tissues. By analyzing these patterns, researchers can assess whether FAPI PET imaging can serve as a reliable and sensitive biomarker for inflammatory activity in SS. This information could be instrumental in guiding clinical treatment decisions, predicting treatment responses, and identifying potential disease flares.

If the study confirms the effectiveness of FAPI PET in assessing inflammation in SS, it could revolutionize the way the disease is monitored and managed. The ability to non-invasively visualize and quantify inflammation could lead to more personalized treatment strategies, more precise disease monitoring, and ultimately, improved outcomes for individuals living with SS. Furthermore, this research could also open up new avenues for understanding the pathophysiology of SS and other autoimmune conditions, potentially leading to the development of novel therapeutic targets and approaches.

The study will also include a control group of patients with various tumors who are scheduled for 68Ga-FAPI PET/CT as part of their diagnostic workup. This will allow for a comparative analysis of FAPI uptake between inflammatory and malignant lesions, enhancing the specificity assessment of FAPI PET in autoimmune disease.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 68Ga-Fibroblast activation protein Inhibitor

Primary outcomes

  1. Optimal imaging time

    Time frame: up to 3 month

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

  2. Correlation with inflammatory markers

    Time frame: 6 weeks

    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.

  3. Comparative uptake analysis between Sjögren's syndrome and tumor patients

    Time frame: up to 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiarou Wang, MD

CONTACT

[email protected]

13628477019

Zhaohui Zhu, MD

CONTACT

[email protected]

13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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