At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 47 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 30
- Started
- 2024-09-01
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for crohn disease
- • Clinical study - 30 participants
- • Crohn's Disease (CD) is a chronic inflammatory condition that can affect any part of the intestine and currently has no cure
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with crohn disease
Where?
- • Edinburgh - NHS Lothian
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Crohn's disease with ileal involvement (including those with disease recurrence in the neo-terminal ileum) due to...
Who cannot take part
- ✗Inability or unwilling to give agreement to take part.
- ✗History of claustrophobia or feeling of inability to tolerate supine position for the PET/MRI or PET/CT scans.
- ✗Impaired kidney 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
See the full criteria
Where Is This Study? (1 UK site)
NHS Lothian
Edinburgh, United Kingdom
How to Get in Touch
Rahul Kalla, MBChB PhD
Sponsor contactCONTACT