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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Dalia A Lartey, MD
d.a.lartey@amsterdamumc.nl
+31205668160
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 20
Treatments
Experimental: IBD patients
Ulcerative colitis and Crohn's disease patients
Sponsors
Leads: Dalia Lartey

This content was sourced from clinicaltrials.gov