Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC Stichting
- Trial code
- EU 2025-522834-30-01
- Record updated
- 2026. június 29.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: ≥ 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.
Exclusion: Previous anti-fibrotic treatment except for end-stage ILD; 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; Pregnancy or lactating; Not able to provide written consent; IBD: colorectal carcinoma or high-grade dysplasia.