Crohn's disease Inflammatory bowel disease ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Group 1 - Adults >=18 years with confirmed diagnosis of Crohn*s disease AND one of the following: - Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms. - Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg) - Active disease confiremed by endoscopy ( endoscopic SES-CD score >3) - Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease) Group 2 - Adults >=18 years with confirmed diagnosis of ulcerative colitis AND one of the following: - Active disease confirmed by endoscopy (endoscopic Mayo score >= 2) or - Active disease confirmed by intestinal ultrasound (BWT > 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter) - Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
Exclusion criteria
Exclusion criteria: - Pregnancy - Unable to provide informed consent - IBD-related surgeries less than 5 years ago in medical history - Colorectal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Visual and quantitative 68Ga-FAPi uptake measurements in the terminal ileum and colon on baseline PET/CT of stricturing Crohn*s disease patients compared to bowel reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent available). 2. Visual and quantitative 68Ga-FAPi uptake measurements in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent available). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi in patients with a) Crohn*s disease and b) ulcerative colitis compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent is available). 2. To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn*s disease and ulcerative colitis. 3. Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET. Exploratory endpoint: To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds to conventional imaging modalities and FAP protein and transcriptome expression levels. | — |
Countries
Netherlands
Outcome results
None listed