FAPi-PET imaging of in vivo fibrosis in inflammatory bowel disease patients

Recruiting

• Conditions: Crohn's disease; Inflammatory bowel disease; ulcerative colitis; 10017969

• Registration Number: NL-OMON53519
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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 less than 5 years ago in medical history
- Colorectal cancer

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Visual and quantitative 68Ga-FAPi uptake measurements in the terminal ileum<br /><br>and colon on baseline PET/CT of stricturing Crohn*s disease patients compared<br /><br>to bowel reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging<br /><br>studies in patients not suffering from IBD (when signed informed consent<br /><br>available).<br /><br>2. Visual and quantitative 68Ga-FAPi uptake measurements in the terminal ileum<br /><br>and colon on baseline PET/CT of ulcerative colitis patients compared to bowel<br /><br>reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in<br /><br>patients not suffering from IBD (when signed informed consent available). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of<br /><br>68Ga-FAPi in patients with a) Crohn*s disease and b) ulcerative colitis<br /><br>compared to bowel uptake reference values as derived in other Amsterdam UMC<br /><br>68Ga-FAPi imaging studies in patients not suffering from IBD (when signed<br /><br>informed consent is available).<br /><br>2. To define optimal (single and/or dual) time point(s) post injection for<br /><br>imaging FAP activity in Crohn*s disease and ulcerative colitis.<br /><br>3. Determine the minimal tracer injection dose required to have comparable<br /><br>disease detection performance on PET as to the full tracer injection dose PET.<br /><br><br /><br>Exploratory endpoint:<br /><br>To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds<br /><br>to conventional imaging modalities and FAP protein and transcriptome expression<br /><br>levels.</p><br>