RECRUITINGPhase 2INTERVENTIONAL
FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
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