RecruitingPhase 2NCT06604260

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

Sponsor

Dalia Lartey

Enrollment

20 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

IBD (Inflammatory Bowel Disease)Ulcerative Colitis (UC)Crohn Disease (CD)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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)