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Taking people in NetherlandsPhase 2

Imaging scarring in lung, skin and bowel diseases driven by inflammation

Tests a PET/CT scan for detecting fibrosis in adults with inflammatory fibrotic diseases.

Key facts

Who runs it
Amsterdam UMC Stichting
Where
Amsterdam, NetherlandsSee the site
Trial code
Registry title
Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases
Status
Recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
24 Jul 2026
Expected to end
30 Sept 2029
Type of study
Interventional
Record updated
29 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a fibrosing immune-mediated disease (such as Crohn's disease, ulcerative colitis, systemic sclerosis, inflammatory myopathy or a fibrosing lung disease) who can have a 68Ga-FAPi PET/CT scan.

Age
18 years or older
Sex
All sexes
Disease stage
Crohn's disease: confirmed fibrostenotic disease, with or without active inflammation. Ulcerative colitis: therapy-refractory disease needing surgery, or quiet disease with surveillance endoscopy. Systemic sclerosis: active lung disease (ILD), non-progressive ILD over two years, or end-stage ILD. Inflammatory myopathy: active myositis needing immunosuppressive drugs, with or without ILD. FHP, uILD and IPF: at least 20% of the lung affected on HRCT with signs of fibrosis, FVC 45% or more, FEV1/FVC 0.7 or more, DLco 40% or more.
Earlier treatment
People who had anti-fibrotic treatment cannot join, except in end-stage ILD.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Cannot give written consent
  • Previous anti-fibrotic treatment (except end-stage ILD)
  • Bowel disease: colorectal cancer or high-grade dysplasia
  • Lung disease: combined pulmonary fibrosis and emphysema, uncontrolled severe asthma, or active cancer (with a few exceptions)

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • ≥ 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

Who cannot take part

  • 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

Where in Netherlands

  • Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases
Plain-language title
Imaging scarring in lung, skin and bowel diseases driven by inflammationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
29 June 2026