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Unravelling intestinal fibrosis in ulcerative colitis: INTERACT study

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507907-73-00
Enrollment
10
Registered
2023-12-08
Start date
2024-04-03
Completion date
2025-10-23
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

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

DRUGGalliUC 370 MBq/mL precursor radiofarmacêutico
DRUGsolução

Sponsors

Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026