Status:
RECRUITING
FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
Lead Sponsor:
Dalia Lartey
Conditions:
IBD (Inflammatory Bowel Disease)
Crohn Disease (CD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 cellu...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Unable to provide informed consent
- IBD-related surgeries \< 5 years in medical history
- Colorectal carcinoma
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06604260
Start Date
August 31 2023
End Date
December 31 2024
Last Update
September 19 2024
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1081 BT