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

Recruitingn/aAges 18 Years - 90 YearsAllUniversity of Edinburgh
NCT07152431 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 of £1 billion per year. Recent data suggests that the despite significant progress in treatments over the last 2 decades to help control disease, up to half of patients still develop progressive bowel scarring that require surgery and up to 70% needing surgery within 10-20 years from diagnosis. Unfortunately this is not a cure and some still require repeat surgery. These features have a devastating impact on an individual including education, work and social life. All our current treatments focus on resolving inflammation but there are no treatments targeting fibrosis, its activity and its progression. A major hurdle in our progress towards anti-fibrotic treatments and advancing care in CD

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
NHS Lothian
Edinburgh, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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