Crohn's Disease · Inflamatory Bowel Disease · Intestinal Fibrosis · Intestinal Strictures Related to Crohn´s Disease
Ga68-FAPI-46 PET/CT Imaging for Small Bowel Fibrosis in Crohn's Disease
This study is investigating whether Ga68-FAPI-46 positron emission tomography/computed tomography (PET/CT) can detect fibrotic changes in adults with small bowel Crohn's disease, including changes that may develop before a stricture.
Registry title: 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Ga68-FAPI-46
- Design
- Not provided
- Central study contact
- Brian Will507-266-0111will.brian@mayo.edu
- Sponsor
- Mayo Clinic
Research question
Can uptake of the Ga68-FAPI-46 tracer on PET/CT identify and characterize fibrostenosing changes in the small bowel, including early changes before a Crohn's disease stricture develops?
Participant snapshot
Who the study is looking for
- The study is looking for adults older than 18 years.
- The study is looking for people with small bowel Crohn's disease diagnosed by a gastroenterologist.
- The study includes people with and without small bowel strictures, based on CT or MR enterography findings.
- The study requires research or clinical MR enterography, or clinical CT enterography, performed within the previous three months.
- The only listed study location is Mayo Clinic in Rochester, Minnesota.
Participation overview
What participation may involve
Participants receive an intravenous Ga68-FAPI-46 radioactive tracer and undergo PET/CT imaging. Their recent CT or MR enterography findings determine whether they are compared in the case or control group. What participation may involve: - Receive Ga68-FAPI-46 through an intravenous line at a listed dose of 5 millicuries, plus or minus 10%. - Complete PET/CT imaging with Ga68-FAPI-46. - Provide recent research or clinical MR enterography, or clinical CT enterography, performed within three months.
Study interventions
What participants may receive or do
- Ga68-FAPI-46: Participants receive 5 millicuries, plus or minus 10%, of gallium-68-labeled fibroblast activation protein inhibitor-46 through an intravenous line for PET/CT imaging.
Study design
How the comparison works
This is an early phase 1 diagnostic study in which all participants are in one intervention group and receive Ga68-FAPI-46 PET/CT. Researchers compare tracer-uptake patterns between participants classified as cases or controls according to CT or MR enterography findings. The study is open-label, meaning the registry reports no masking. The control comparison consists of participants who have small bowel Crohn's disease without a stricture; they may have inflammation, luminal narrowing, postoperative or chronic changes, or no active inflammation. No placebo or sham intervention is listed; the single study arm receives Ga68-FAPI-46 PET/CT.
Reported activities
Procedures and tests
- Ga68-FAPI-46 is administered through an intravenous line.
- Participants undergo PET/CT imaging after receiving Ga68-FAPI-46.
- Screening may involve confirming that eligible participants had research or clinical MR enterography, or clinical CT enterography, within the previous three months.
- CT or MR enterography findings are used to classify participants as cases with a stricture or probable stricture, or controls without a stricture.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must have known small bowel Crohn's disease.
- The Crohn's disease diagnosis must have been made by a gastroenterologist.
- Participants must have research or clinical MR enterography, or clinical CT enterography, from within the previous three months.
- Participants must be older than 18 years.
- Participants must be willing to undergo Ga68-FAPI-46 PET/CT.
- Participants must be able to give informed consent and willing to provide written consent.
Possible reasons someone may not be able to join
- People who are pregnant or breastfeeding are excluded.
- People with hypersensitivity to any ingredient used in Ga68-FAPI-46 are excluded.
Important unknowns
What the record does not make clear
- The registry does not state how many study visits are required or how they are scheduled.
- The registry gives study-wide outcome and completion timeframes but does not state how long an individual participates.
- The registry does not say whether participants continue their usual Crohn's disease treatments during the study.
- The registry does not report any medication washout or timing requirements.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not state whether travel, lodging, parking, or meal support is available.
- The record does not say whether any screening or follow-up activities can be completed remotely.
- The registry lists the tracer dose but does not describe preparation instructions, radiation exposure, possible side effects, or monitoring after administration.
Before contacting the site
Questions for the study team
- How many visits are required, how long does each take, and what happens at each visit?
- How long will my participation last from screening through the final study activity?
- May I continue my current Crohn's disease medicines, and are there any medication restrictions before imaging?
- What preparation, radiation exposure, possible side effects, and monitoring are involved with the tracer and PET/CT?
- Can my existing CT or MR enterography be used, and how will you decide whether I am in the case or control comparison?
- Which costs are covered, is compensation offered, and is travel assistance available?
- Can any screening or follow-up be completed remotely, or must all activities occur in Rochester?
Before changing care
Questions for your gastroenterologist
- Would participating interfere with the timing or continuity of my current Crohn's disease treatment?
- How stable is my Crohn's disease now, and are there reasons related to inflammation, narrowing, strictures, or penetrating complications that I should discuss with the study team?
- What approved imaging or treatment alternatives are relevant to my current clinical care, separate from this research scan?
- What risks or practical concerns from the radioactive tracer and PET/CT are especially relevant to my health history and current medicines?
- How should you and the research team coordinate my imaging results and ongoing Crohn's disease care?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. The goal is to determine whether areas of early or developing fibrosis ("pre-stricture" changes) demonstrate uptake of the tracer, which binds to fibroblast activation protein (FAP). Participants with small bowel Crohn's disease will be assigned to either a case or control group based on CT or MR enterography findings at enrollment. Cases will include participants who have a small bowel stricture or probable stricture, with or without penetrating complications. Controls will include participants with small bowel Crohn's disease without strictures. Controls may have active inflammatory disease, luminal narrowing, or no active inflammation (including postoperative or chronic changes), as long as no stricture is present. Because most radiologic strictures represent more advanced fibrostenosis, the study aims to enroll a larger proportion of controls to better characterize early fibrotic changes. Approximately one-third to one-half of participants will be cases, and the remainder controls. This design will allow comparison of FAPI uptake patterns in patients with and without strictures to understand how FAP expression relates to the development of small bowel fibrosis.
Study design and administration
- Organization
- Mayo Clinic
- Organization class
- Other
- Organization study ID
- 25-008885
- Lead sponsor
- Mayo Clinic
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Diagnostic
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
A group of participants getting PET/CT scan with 68Ga-FAPI-46
Ga68-FAPI-46 radioactive tracer binding to FAP
Interventions: Drug: Ga68-FAPI-46
Interventions
Drug
Ga68-FAPI-46
Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (6)
- Known small bowel Crohn's diseaseRegistry-derived · unreviewed
- Research or clinical MR enterography, or clinical CT enterography, within 3 months.Registry-derived · unreviewed
- Male or female with age greater than 18 years old.Registry-derived · unreviewed
- Diagnosis of Crohn's disease by a gastroenterologistRegistry-derived · unreviewed
- Willingness to undergo 68Ga-FAPI-46 PET/CTRegistry-derived · unreviewed
- Subjects with the capacity to give informed consent and willingness to provide written consentRegistry-derived · unreviewed
Exclusion criteria (2)
- Pregnant and/or breast-feeding subjects.Registry-derived · unreviewed
- Hypersensitivity to any excipients in 68Ga-FAPI-46Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Completion of PET/CT with Ga68-FAPI-46 by all participants
Time frame: Through study completion, an average of 2 years
Primary outcome
Number of participants completing PET/CT with Ga68-FAPI-46
Time frame: Through study completion, an average of 2 years
Participants complete PET/CT with Ga68-FAPI-46
Recruiting locations in the United States
Mayo Clinic
RecruitingRochester, Minnesota, 55905, United States
Bruce S Lee, Ph.D.507-538-4446lee.yong@mayo.edu
Bruce L Will507-266-0111will.brian@mayo.edu
Central study contacts
Registry dates
- First posted
- Dec 9, 2025
- Primary completion
- Feb 28, 2027
- Overall completion
- Apr 30, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.