FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- IBD (Inflammatory Bowel Disease)
- Sponsor
- Dalia Lartey
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients
- Status
- Recruiting
- Last Updated
- last year
Overview
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 cellular FAP expression in intestinal biopsies and resection specimens.
Investigators
Dalia Lartey
Drs
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •Pregnancy
- •Unable to provide informed consent
- •IBD-related surgeries \< 5 years in medical history
- •Colorectal carcinoma
Outcomes
Primary Outcomes
Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients
Time Frame: At baseline up to week 12 of study enrolment
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn's disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients
Time Frame: At baseline up to week 12 of study enrolment
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
Secondary Outcomes
- Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi(At baseline up to week 12 of study enrolment)
- Protocol optimisation(At baseline up to week 12 of study enrolment)
- Minimal tracer injection dose(At baseline up to week 12 of study enrolment)