Ulcerative colitis
Conditions
Brief summary
Identified pathways obtained via pathway analysis (single-cell RNA sequencing). Changes in these identified pathways (in gene and protein expression at week 24 compared to week 0)
Detailed description
Binding of [68Ga]Ga-FAPi-46 will be measured using the standardized uptake value (SUV) and target to background ratios will aid in scoring and quantifying tracer uptake. Semi-quantitative uptake above local background will be corrected and uncorrected for tracer plasma concentration based on pharmacokinetic analysis. SUV quantified from the FAPi-PET/CT-scan participants will be compared to non-affected intestinal regions. FAPi PET uptake expressed as SUV. Percentage of SUV decrease at week 24., Changes in gene and protein expression levels expressed as percentages in mucosal biopsies at week 0 and at week 24 (increased/ decreased an to what degree this corresponds to the SUV., Changes in FAPi PET uptake and correlation to clinical (SCCAI score) and endoscopic (Mayo score) changes.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identified pathways obtained via pathway analysis (single-cell RNA sequencing). Changes in these identified pathways (in gene and protein expression at week 24 compared to week 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Binding of [68Ga]Ga-FAPi-46 will be measured using the standardized uptake value (SUV) and target to background ratios will aid in scoring and quantifying tracer uptake. Semi-quantitative uptake above local background will be corrected and uncorrected for tracer plasma concentration based on pharmacokinetic analysis. SUV quantified from the FAPi-PET/CT-scan participants will be compared to non-affected intestinal regions. FAPi PET uptake expressed as SUV. Percentage of SUV decrease at week 24., Changes in gene and protein expression levels expressed as percentages in mucosal biopsies at week 0 and at week 24 (increased/ decreased an to what degree this corresponds to the SUV., Changes in FAPi PET uptake and correlation to clinical (SCCAI score) and endoscopic (Mayo score) changes. | — |
Countries
Netherlands