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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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) Who Should NOT Join This Trial: - Pregnancy - Unable to provide willing to sign a consent form - IBD-related surgeries \< 5 years in medical history - Colorectal carcinoma Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

68Ga-FAPi-46

68Ga FAPi PET-CT scan

Locations (1)

Amsterdam UMC
Amsterdam, North Holland, Netherlands