Imaging intestinal fibrosis in patients with inflammatory bowel disease
FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
This study is testing a new imaging technique to see if it can help find intestinal scarring in people with inflammatory bowel disease like Crohn's disease and ulcerative colitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06604260 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using 68Ga-FAPi PET/CT imaging to detect intestinal fibrosis in patients diagnosed with inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis. The research aims to correlate the uptake of 68Ga-FAPi with fibroblast activation protein (FAP) expression in intestinal biopsies and resection specimens. By assessing these relationships, the study seeks to improve diagnostic capabilities for fibrosis in IBD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Crohn's disease or ulcerative colitis who exhibit active disease symptoms.
Not a fit: Patients who are pregnant or have undergone IBD-related surgeries within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for detecting fibrosis in IBD, potentially guiding more effective treatment strategies.
How similar studies have performed: While the use of PET imaging in IBD is an emerging field, this specific approach using 68Ga-FAPi PET/CT for fibrosis detection is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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: * Pregnancy * Unable to provide informed consent * IBD-related surgeries \< 5 years in medical history * Colorectal carcinoma
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Mark Lowenberg, MD PhD — Amsterdam UMC
- Study coordinator: Dalia A Lartey, MD
- Email: d.a.lartey@amsterdamumc.nl
- Phone: +31205668160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.