New PET tracer aims to spot hidden scarring in Crohn's patients
NCT ID NCT07273188
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests whether a special PET scan tracer, Ga68-FAPI-46, can detect early fibrosis (scarring) in the small bowel of people with Crohn's disease. About 45 participants will be divided into those with known strictures and those without, to compare scan results. The goal is to improve diagnosis of fibrostenosing Crohn's, which currently is hard to detect early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ga68-FAPI-46 (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could lead to a new way to detect early scarring in Crohn's disease, helping doctors identify and treat fibrosis before it causes blockages.
- What could go wrong
- This is a very early, small study (45 people) testing a diagnostic method, not a treatment. The tracer may not reliably distinguish early fibrosis from inflammation, and results may not apply to all patients.
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.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Known small bowel Crohn's disease * Research or clinical MR enterography, or clinical CT enterography, within 3 months. * Male or female with age greater than 18 years old. * Diagnosis of Crohn's disease by a gastroenterologist * Willingness to undergo 68Ga-FAPI-46 PET/CT * Subjects with the capacity to give informed consent and willingness to provide written consent Exclusion Criteria: * Pregnant and/or breast-feeding subjects. * Hypersensitivity to any excipients in 68Ga-FAPI-46
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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