Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- FAPI uptake on PET/CT
研究概览
简要总结
To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.
详细描述
To evaluate the use of the fibroblast activation protein (FAP) as a biomarker of fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) and non-IPF ILDs). The study will include both analysis of FAP expression in samples stored in the biobank of the department of Pneumology (BAL, blood, induced sputum and EBC) (cohort A) and lung FAPI uptake on PET/CT scans performed at the department of Nuclear Medicine:
- before and after the initiation of an antifibrotic therapy (IPF or PPF) (cohort B)
- before and after the initiation of corticosteroid therapy in case of an acute exacerbation of ILD (cohort C)
- before and after the initiation of an immunosuppressive drug in the context of non-IPF pulmonary fibrosis (cohort D).
- before lung transplantation, surgery or biopsy to correlate with FAP expression determined by immunohistochemical analysis (IHC) (cohort E).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients with a fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) or non-IPF fibrotic ILD) as defined according to the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelines
排除标准
- •Pregnant or nursing patients
- •Patients with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
- •Patients with an active lung neoplasm or any active neoplasm for blood samples
结局指标
主要结局
FAPI uptake on PET/CT
时间窗: From date of inclusion till date of the second FAPI PET/CT (after 3 months)
Decrease in lung FAPI uptake after the initiation of treatment, measured with the following PET parameters: SUVmax, SUVmean and Total lesion fapi uptake (TLA) in the lungs of the patients
次要结局
- Correlation between lung FAP expression and clinical evolution(From date of inclusion for a period of 2 years)
- Correlation between lung FAPI uptake and corresponding FAP assessment in blood and BAL samples.(From date of inclusion till last BAL sample taken, up to a maximum period of 2 years follow-up)
- Correlation between lung FAPI uptake and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy)(From date of inclusion until surgery, for a maximum period of 2 years)
- Comparison of different FAPi tracers(From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks))