FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
Recruiting · NCT06604260 · Interventional (participants receive a specific treatment) · Lead sponsor: Dalia Lartey
View the official record on ClinicalTrials.gov →Interventions studied
68Ga-FAPi-46
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed.
- Amsterdam UMC - Amsterdam, North Holland, Netherlands
- Amsterdam UMC - Amsterdam, North Holland, Netherlands