FAPI PET imaging to find fibrotic bowel in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses a FAPI radiotracer with PET/MRI or PET/CT to image the small bowel in people with Crohn's disease involving the ileum. Participants will be scanned to look for signals that indicate fibrotic tissue rather than active inflammation. Eligible patients are those with ileal disease (including neo-terminal ileum recurrence) who are due to begin biologic therapy and who can tolerate the imaging procedures. Standard safety exclusions apply, including pregnancy, severe renal impairment, MRI contraindications, claustrophobia, and relevant drug allergies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where it's running

• NHS Lothian
  Edinburgh, United Kingdom Recruiting

Study contacts

• Study coordinator: Rahul Kalla, MBChB PhD
• Email: rahul.kalla@ed.ac.uk
• Phone: 0131 651 8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.