FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
- Conditions
- IBD (Inflammatory Bowel Disease)Crohn Disease (CD)Ulcerative Colitis (UC)
- Interventions
- Diagnostic Test: 68Ga-FAPi-46
- Registration Number
- NCT06604260
- Lead Sponsor
- Dalia Lartey
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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)
- Pregnancy
- Unable to provide informed consent
- IBD-related surgeries < 5 years in medical history
- Colorectal carcinoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IBD patients 68Ga-FAPi-46 Ulcerative colitis and Crohn's disease patients
- Primary Outcome Measures
Name Time Method Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients 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 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 Outcome Measures
Name Time Method Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi At baseline up to week 12 of study enrolment Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi in patients with a) Crohn's disease and b) ulcerative colitis compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent is available).
Protocol optimisation At baseline up to week 12 of study enrolment To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn's disease and ulcerative colitis.
Minimal tracer injection dose At baseline up to week 12 of study enrolment Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET.
Trial Locations
- Locations (1)
Amsterdam UMC
🇳🇱Amsterdam, Noord-Holland, Netherlands