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

Dalia Lartey

Status and phase

Enrolling

Phase 2

Conditions

IBD (Inflammatory Bowel Disease)

Ulcerative Colitis (UC)

Crohn Disease (CD)

Treatments

Diagnostic Test: 68Ga-FAPi-46

Study type

Interventional

Funder types

Other

Identifiers

NCT06604260

2022-002751-19 (EudraCT Number)

NL82160.029.22

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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