Fibroblast Activation Protein Inhibitor, Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
PET CT, FAPI, IBD, Ulcerative colitis, Filgotinib
Brief summary
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_TESTFibroblast Activation Protein Inhibitor
PET CT imaging using the fibroblast activation protein inhibitor tracer
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Half of the study participants will undergo PET CT imaging. Therefore, the interventional study model only applies to half of the study partcipants.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Candidate fibrotic cellular pathways | From enrollment to end of study participation at 24 weeks | Identification of candidate fibrotic cellular pathways using single cell pathway analysis and mucosal biopsies from UC patients before and at week 24 weeks after treatment initiation with filgotinib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 68Ga-FAPi-PET/CT imaging feasibility | From enrollment to end of study participation at 24 weeks | Feasilibility 68Ga-FAPi-PET/CT imaging as biomarker to monitor in vivo fibrosis in UC. By detection of in vivo intestinal fibrosis by means of measuring 68Ga-FAPi uptake, both visually as semi-quantitatively, in UC patients using FAPi-PET/CT imaging at baseline and 24 weeks after treatment initiation with filgotinib. |
| Correspondance 68Ga-FAPi uptake and STAT expression | From enrollment to end of study participation at 24 weeks | To determine to what extent 68Ga-FAPi bowel uptake in UC patients corresponds to (phospohorylated and total) STAT gene and protein (i.e. down-stream JAK targets) expression |
| Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters | From enrollment to end of study participation at 24 weeks | To determine to what extent 68Ga-FAPi bowel uptake in UC patients corresponds to clinical and endoscopic changes after 24 weeks of treatment with filgotinib |
Countries
Netherlands
Contacts
Primary ContactDalia A Lartey, MD
Backup ContactKelly van Wijnbergen, Msc
Outcome results
None listed