Authorised Therapeutic exploratory (Phase II) Systemic sclerosis (SSc)

Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases

EU CTIS ID: 2025-522834-30-01

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • ≥ 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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.