FAPI PET imaging to find fibrotic bowel in Crohn's disease
FATE-CD: A Prospective Cohort Observational Study Investigating the Role of Fibrosis Activity in Crohn's Disease
This project will try FAPI PET imaging to see if it can detect bowel scarring in people with ileal Crohn's disease who are about to start biologic treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT07152431 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with Crohn's disease involving the ileum (including neo-terminal ileum recurrence) who are due to start biologic therapy and can undergo PET/MRI or PET/CT are ideal candidates.
Not a fit: People with Crohn's disease limited to the colon, pregnant or breastfeeding women, those with severe renal impairment, MRI contraindications, severe claustrophobia, or contraindications/allergy to buscopan are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive way to identify bowel scarring so clinicians can tailor treatment and plan surgery more accurately.
How similar studies have performed: FAPI PET imaging is a novel approach with encouraging early results in detecting fibrosis in other organs, but its use for intestinal fibrosis in Crohn's disease is still experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Edinburgh
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rahul Kalla, MBChB PhD
- Email: rahul.kalla@ed.ac.uk
- Phone: 0131 651 8100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.