Crohn DiseaseFATE-CDNCT07152431
Fibrosis Associated Protein Inhibitor (FAPI) Radiotracer-based Imaging to Identify Fibrotic Intestinal Crohn's Disease
An observational study of Crohn Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Crohn Disease
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2024to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Crohn's disease and small bowel involvement
Who may be able to join
- Crohn's disease with ileal involvement (including those with disease recurrence in the neo-terminal ileum) due to commence biologics.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Lothian
Edinburgh
Rahul Kalla
About this study
Official title: FATE-CD: A Prospective Cohort Observational Study Investigating the Role of Fibrosis Activity in Crohn's Disease
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
- Crohn Disease
- Keywords
- fibrosis
- Medical subject headings
- Crohn Disease, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152431
- Sponsor's protocol ID
- 332586
- Acronym
- FATE-CD
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FATE-CD: A Prospective Cohort Observational Study Investigating the Role of Fibrosis Activity in Crohn's Disease
- ClinicalTrials.gov ID
- NCT07152431
- Acronym / sponsor ID
- FATE-CD / 332586
- Conditions
- Crohn Disease
- Keywords
- fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Crohn's disease and small bowel involvement
Key inclusion criteria (1 listed)
- Crohn's disease with ileal involvement (including those with disease recurrence in the neo-terminal ileum) due to commence biologics.
Key exclusion criteria (10 listed)
- Inability or unwilling to give informed consent.
- anaphylaxis) to buscopan use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibrosis activity
Time frame: 36 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahul Kalla, MBChB PhD (0131 651 8100, rahul.kalla@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis activity (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.