2023-503686-26-00撤回2 期
PET/CT imaging with FAPI as a biomarker for the distinction between predominant active fibrotic and inflammatory phenotypes in patients with progressive pulmonary fibrosis: The FIBRO-PET study.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FAPI activity concentration in patients with predominant active fibrosis and predominant inflammation
研究概览
简要总结
To test the feasibility of differentiating predominant active fibrosis and predominant inflammation using PET imaging with FAPI in patients with PPF.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •New diagnosis of PPF
- •A minimum of 20% of lung parenchyma is aberrant (fibrosis, inflammation or both)
- •MDT indication for treatment with either immunosuppressive drugs or antifibrotic drug
排除标准
- •Prior or current treatment with antifibrotic drugs
- •Active malignancy
- •Inability to undergo a PET/CT at the Sint Antonius Hospital
- •Incapacity to give informed consent personally
结局指标
主要结局
FAPI activity concentration in patients with predominant active fibrosis and predominant inflammation
FAPI activity concentration in patients with predominant active fibrosis and predominant inflammation
次要结局
- Activity thresholds for positive FAPI-PET/CT confirming active fibrosis,
- Correlation between baseline FAPI activity and ILD extent/degree of reticulation on HRCT as well as serum biomarkers for inflammation
研究者
Andor van den Hoven
Scientific
St Antonius Hospital
研究点 (1)
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