Recruiting NCT06604273
Unravelling Intestinal Fibrosis in Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fibroblast Activation Protein Inhibitor.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Fibroblast Activation Protein Inhibitor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The main objectives are: (i) to identify candidate fibrotic cellular pathways in UC patients treated with a JAK inhibitor filgotinib), and (ii) to detect and monitor in vivo fibrosis in UC patients using FAPi-PET/CT imaging
Interventions
- Diagnostic test Fibroblast Activation Protein Inhibitor
PET CT imaging using the fibroblast activation protein inhibitor tracer
Primary outcome measures
- Candidate fibrotic cellular pathways [Time frame: From enrollment to end of study participation at 24 weeks]
Secondary outcome measures (3)
- 68Ga-FAPi-PET/CT imaging feasibility [Time frame: From enrollment to end of study participation at 24 weeks]
- Correspondance 68Ga-FAPi uptake and STAT expression [Time frame: From enrollment to end of study participation at 24 weeks]
- Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters [Time frame: From enrollment to end of study participation at 24 weeks]
Eligibility criteria
Inclusion criteria
- Adults with confirmed diagnosis of UC - Group 1 criterion: ≥18 years of age regardless of gender
- Group 2 criterion: ≥30 years of age for males and ≥40 years of age for females
- Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2)
- Indication to start treatment with filgotinib
AND one of the following criteria:
- Active disease confirmed by intestinal ultrasound (BWT \> 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or
- Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)
Exclusion criteria
- Pregnancy
- Unable to provide informed consent
- Colorectal carcinoma or high-grade dysplasia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT06604273 · NL85277.018 · 2023-507907-73-00