Crohn Disease (CD), IBD (Inflammatory Bowel Disease), Ulcerative Colitis (UC)
Conditions
Keywords
FAPI, fibroblast activation protein, FAP, FAPi-scan, 68Ga-FAPi PET-CT
Brief summary
Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens.
Interventions
DIAGNOSTIC_TEST68Ga-FAPi-46
68Ga FAPi PET-CT scan
Sponsors
Dalia Lartey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Pregnancy * Unable to provide informed consent * IBD-related surgeries < 5 years in medical history * Colorectal carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients | At baseline up to week 12 of study enrolment | Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn's disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available). |
| Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients | At baseline up to week 12 of study enrolment | Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi | At baseline up to week 12 of study enrolment | 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). |
| Protocol optimisation | At baseline up to week 12 of study enrolment | To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn's disease and ulcerative colitis. |
| Minimal tracer injection dose | At baseline up to week 12 of study enrolment | Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correspondence 68Ga-FAPi bowel uptake conventional imaging modalities and cellular FAP | At baseline up to week 12 of study enrolment | 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
Contacts
Primary ContactDalia A Lartey, MD
Outcome results
None listed