Status:

RECRUITING

Fibrosis Associated Protein Inhibitor (FAPI) Radiotracer-based Imaging to Identify Fibrotic Intestinal Crohn's Disease

Lead Sponsor:

University of Edinburgh

Conditions:

Crohn Disease

Eligibility:

All Genders

18-90 years

Brief Summary

Crohn's Disease (CD) is a chronic inflammatory condition that can affect any part of the intestine and currently has no cure. It affects 6.8 million people worldwide with UK healthcare costs in excess...

Eligibility Criteria

Inclusion

  • Crohn's disease with ileal involvement (including those with disease recurrence in the neo-terminal ileum) due to commence biologics.

Exclusion

  • Inability or unwilling to give informed consent.
  • History of claustrophobia or feeling of inability to tolerate supine position for the PET/MRI or PET/CT scans.
  • Impaired renal function with eGFR of \<30 mL/min/1.73m2
  • Women who are pregnant or breastfeeding. Pregnancy test will be performed in all women of childbearing age
  • Contrast allergy
  • Contraindication to MRI (e.g. metallic implant or severe claustrophobia)
  • Significant mental health conditions that will impair the ability to consent or affect their ability to take part in the study
  • Patients with colonic disease only with no ileal or small bowel involvement.
  • Contraindications (Glaucoma and/or ischaemic heart disease) or allergy (eg:
  • anaphylaxis) to buscopan use.

Key Trial Info

Start Date :

September 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2028

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT07152431

Start Date

September 1 2024

End Date

August 1 2028

Last Update

September 22 2025

Active Locations (1)

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1

NHS Lothian

Edinburgh, United Kingdom