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Could a dye reveal hidden scarring in Crohn's patients?

NCT ID NCT07152431

Knowledge-focused Sponsor: University of Edinburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study tests a new imaging method using a special dye (FAPI) to detect bowel scarring in people with Crohn's disease. Scarring affects up to half of patients and often leads to surgery, but current tests can't spot it early. The study will involve 30 adults starting biologic treatment, who will receive PET/CT scans to see if the dye can track scarring activity. If it works, this could pave the way for new drugs that prevent permanent bowel damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FAPI (fibrosis associated protein inhibitor) dye used with PET/CT imaging
What this could lead to
If successful, this could be the first non-invasive way to detect and track bowel scarring in Crohn's disease, helping develop new anti-fibrotic treatments.
What could go wrong
This is a small, early observational study with only 30 participants. It tests a detection method, not a treatment, so it may not directly improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals with Crohn's disease and small bowel involvement

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Crohn disease Crohn ileitis Fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NHS Lothian

    RECRUITING

    Edinburgh, United Kingdom

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