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RecruitingNCT07152431FATE-CDUpdated Sep 18, 2026

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

An observational study in Crohn Disease, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by University of Edinburgh · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Crohn Disease

Keywords

  • fibrosis
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In context

Crohn Disease

1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.

This study's planned enrollment of 30 is below the median of 185 across 645 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with Crohn's disease and small bowel involvement

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability or unwilling to give .

    • History of claustrophobia or feeling of inability to tolerate supine position for the PET/MRI or PET/CT scans.
    • Impaired renal function with 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
    • 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Fibrosis activity

    To establish and quantify the intestinal fibrosis activity in patients with active fibrostenosing Crohn's disease phenotype (Montreal B2) and assess its utility in predicting fibrosis progression over time

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07152431
Responsible party
Sponsor
First posted
Sep 3, 2025
Start date
Sep 1, 2024
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Sep 18, 2026

Study contacts

Rahul Kalla, MBChB PhD
Contact
rahul.kalla@ed.ac.uk
0131 651 8100

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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