Actively Recruiting
Fibrosis Associated Protein Inhibitor (FAPI) Radiotracer-based Imaging to Identify Fibrotic Intestinal Crohn's Disease
Led by University of Edinburgh · Updated on 2025-09-22
30
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 has been our inability to identify bowel scarring accurately using non-invasive tests; this being critical in developing new treatments that prevent permanent bowel damage. We are also unable to identify early stage scarring (fibrosis) and once established we are unable to differentiate between different stages of scarring severity. The investigators aim to investigate a novel method that can identify early scarring and track progressive bowel damage by tracking cells that cause fibrosis. In this study the investigators will use a 'dye', also known as fibrosis associated protein inhibitor (FAPI), that tracks scarring and its activity in the intestine. The presence and amount of FAPI within an area of scarring can be detected using our current imaging tests (positron emission tomography and Computer Tomography imaging: PET/CT). If successful, this study will be the first method for detecting scarring activity in CD and have the potential to revolutionise care for this condition and facilitate new drug development to halt the processing of scarring (fibrosis) and improve the outcomes for patients with CD.
CONDITIONS
Official Title
Fibrosis Associated Protein Inhibitor (FAPI) Radiotracer-based Imaging to Identify Fibrotic Intestinal Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Crohn's disease with ileal involvement, including disease recurrence in the neo-terminal ileum
- Planning to start biologic treatment for Crohn's disease
You will not qualify if you...
- Unable or unwilling to give informed consent
- History of claustrophobia or inability to tolerate lying down for PET/MRI or PET/CT scans
- Impaired kidney function with eGFR less than 30 mL/min/1.73m2
- Women who are pregnant or breastfeeding; pregnancy test required for women of childbearing age
- Allergy to contrast agents
- Contraindications to MRI such as metallic implants or severe claustrophobia
- Significant mental health conditions affecting consent or participation
- Crohn's disease affecting only the colon without ileal or small bowel involvement
- Contraindications or allergy to buscopan (e.g., glaucoma, ischemic heart disease, anaphylaxis)
AI-Screening
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Trial Site Locations
Total: 1 location
1
NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
Research Team
R
Rahul Kalla, MBChB PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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