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FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients

FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients

Recruiting
18 years and older
All
Phase 2

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Overview

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.

Eligibility

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

Study details
    IBD (Inflammatory Bowel Disease)
    Crohn Disease (CD)
    Ulcerative Colitis (UC)

NCT06604260

Dalia Lartey

14 October 2025

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