Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Detection of areas with enhanced 68Ga-FAPi uptake in organs of patients with IBD, CTD or ILD and correlation of imaging outcomes to cellular and serum FAP expression levels
概览
简要总结
To evaluate the use of 68Ga-FAPi PET/CT imaging in detecting in vivo fibrosis and to correlate these findings to cellular and serum FAP levels in patients with IMIDs, and to identify other potential fibrotic biomarkers with diagnostic and/or therapeutic value for IMIDs.
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 and able to undergo a PET/CT-scan and pulmonary function test (if applicable)
- •CD: endoscopically or ultrasonographically confirmed fibrostenotic disease with or without signs of active inflammation
- •UC: therapy-refractory UC requiring surgery or quiescent UC with surveillance endoscopy
- •SSc: SSc with active ILD or non-progressive ILD over two years or end-stage ILD
- •IIM: IIM with active myositis and a clinical need to start imunosupressive agents with or without ILD
- •FHP, uILD and IPF: available chest HRCT data within 12 months prior to screening (or performed at screening), minimum of 20% involvement of the lung parenchyma on HRCT and signs of fibrosis, FVC ≥ 45% predicted from normal, FEV1/FVC ≥ 0.7, DLco corrected for Hb ≥ 40% predicted from normal
排除标准
- •Pregnancy or lactating
- •Not able to provide written consent
- •Previous anti-fibrotic treatment except for end-stage ILD
- •IBD: colorectal carcinoma or high-grade dysplasia
- •ILD: combined pulmonary fibrosis and emphysema, uncontrolled severe asthma, active malignancy (except for squamous cell carcinoma of the skin, low-risk breast cancer and low-risk prostate cancer), signs of upper or lower respitory tract symptoms during the last 6 weeks before screening or circumstances or comorbidities which interfere, by opinion of the investigator, with evaluation of the PET/CT or with the evaluation of progressive pulmonary fibrosis
研究组 & 干预措施
68Ga-FAPI-46
干预措施: 68Ga-FAPI-46 (Drug)
结局指标
主要结局
Detection of areas with enhanced 68Ga-FAPi uptake in organs of patients with IBD, CTD or ILD and correlation of imaging outcomes to cellular and serum FAP expression levels
Detection of areas with enhanced 68Ga-FAPi uptake in organs of patients with IBD, CTD or ILD and correlation of imaging outcomes to cellular and serum FAP expression levels
Transcriptome and proteome analysis of tissue samples for FAP and other potential fibrotic biomarkers as well as regulators of upstream signaling pathways and immune cell markers.
Transcriptome and proteome analysis of tissue samples for FAP and other potential fibrotic biomarkers as well as regulators of upstream signaling pathways and immune cell markers.
次要结局
- Visual and semi-quantitative evaluation of the pharmacokinetics of 68GA-FAPi in patients with CTD and ILD.
- Optimization of the 68Ga-FAPi PET/CT scanning protocol for patients with CTD and ILD.
研究者
M. Löwenberg
Scientific
Amsterdam UMC Stichting