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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507907-73-00 | EU Trial (CTIS) Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 | Experimental | This group undergoes FAPi-PET CT imaging |
|
| Group 1 | No Intervention | Does not undergo a FAPi scan |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroblast Activation Protein Inhibitor | Diagnostic Test | PET CT imaging using the fibroblast activation protein inhibitor tracer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Candidate fibrotic cellular pathways | 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. | From enrollment to end of study participation at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 68Ga-FAPi-PET/CT imaging feasibility | 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. | From enrollment to end of study participation at 24 weeks |
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Inclusion Criteria:
AND one of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalia A Lartey, MD | Contact | +31205668160 | d.a.lartey@amsterdamumc.nl | |
| Kelly van Wijnbergen, Msc | Contact | +31205668160 | k.vanwijnbergen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Mark Lowenberg, MD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1081BT | Netherlands |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Half of the study participants will undergo PET CT imaging. Therefore, the interventional study model only applies to half of the study partcipants.
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| Correspondance 68Ga-FAPi uptake and STAT expression | 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 | From enrollment to end of study participation at 24 weeks |
| Correspondance 68Ga-FAPi uptake and clinical and endoscopic parameters | 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 | From enrollment to end of study participation at 24 weeks |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |