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临床试验/NCT07062523
NCT07062523招募中1 期

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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Optimal imaging time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

Experimental

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

干预措施: 68Ga-FAPI (Drug)

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.

干预措施: 68Ga-FAPI (Drug)

结局指标

主要结局

Optimal imaging time

时间窗: up to 3 month

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

Correlation with inflammatory markers

时间窗: 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.

Comparative uptake analysis between Sjögren's syndrome and tumor patients

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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