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临床试验/NCT07151521
NCT07151521招募中不适用

Application Value of Novel PET Tracers Targeting CAF in ANCA-Associated Vasculitis

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Disease severity and activity in ANCA-associated vasculitis with concomitant interstitial lung disease and renal dysfunction as measured by 68Ga-FAPI PET/CT.

研究概览

简要总结

Pulmonary and renal involvement are the most common clinical manifestations of antineutrophil cytoplasmic antibody(ANCA)-associated vasculitis (AAV). Studies have shown that both interstitial lung disease (ILD) and renal dysfunction are closely associated with poor prognosis in patients with AAV. Therefore, early identification of whether AAV patients have concomitant ILD and renal involvement is of great clinical importance for assessing disease severity, stratifying prognostic risk, and developing individualized treatment strategies.

Positron emission tomography (PET) is a noninvasive molecular imaging technique that can provide decision-making support for early and accurate diagnosis, timely intervention, as well as evaluation of treatment response and prognosis. In the same individual, PET enables whole-body localization of disease in a single examination, overcoming the limitation of conventional diagnostic methods that typically assess only one region at a time, thereby facilitating patient benefit.

In recent years, many novel PET tracers have been developed and introduced into clinical practice. 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) has been studied in the diagnosis of various malignant and nonmalignant diseases; it targets fibroblast activation protein (FAP) and thus reflects the distribution of cancer-associated fibroblasts (CAFs). However, its clinical significance in AAV remains to be further investigated. This study aims to use a CAF-targeted novel PET tracer to conveniently and noninvasively detect the real-time distribution of lesions in patients, providing valuable information for personalized diagnosis and treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Age over 18 years;
  • Meeting the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for ANCA-associated vasculitis;
  • Diagnosed with concomitant interstitial lung disease based on High-Resolution Computed Tomography (HRCT) images obtained within one year prior to enrollment, interpreted by two radiologists blinded to clinical information;
  • Complete clinical information available;
  • Signed and dated informed consent form;
  • Willingness to comply with the study procedures and cooperate throughout the entire study process.

排除标准

  • Presence of other rheumatic diseases;
  • Presence of other conditions that may cause interstitial lung disease or renal impairment, such as systemic lupus erythematosus, dermatomyositis, or rheumatoid arthritis;
  • History of, or planned, hematopoietic stem cell transplantation;
  • Presence of severe comorbidities deemed by the investigators to be unsuitable for participation in this clinical study, such as severe cardiopulmonary insufficiency, severe bone marrow suppression, or severe hepatic or renal insufficiency;
  • Acute abdominal emergencies such as intestinal perforation or complete intestinal obstruction;
  • Pregnant or potentially pregnant women, and lactating women;
  • Poor treatment compliance.

结局指标

主要结局

Disease severity and activity in ANCA-associated vasculitis with concomitant interstitial lung disease and renal dysfunction as measured by 68Ga-FAPI PET/CT.

时间窗: Within 4 weeks after enrollment

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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