Crohn's DiseaseEarly Phase 1FAPI-PETCDNCT07273188
68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
A Early Phase 1 study testing Ga68-FAPI-46 in people with Crohn's Disease and Intestinal Fibrosis, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Intestinal Fibrosis, Inflamatory Bowel Disease
- What is being tested?
- Ga68-FAPI-46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to 30 Apr 2027
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant and/or breast-feeding subjects.
- Hypersensitivity to any excipients in 68Ga-FAPI-46
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Bruce S Lee, Ph.D., 507-538-4446, lee.yong@mayo.edu
Bruce L Will, 507-266-0111, will.brian@mayo.edu
About this study
Official title: Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPI-46) PET in Crohn's Disease Patients: a Case-control Study Designed to Illuminate the Spectrum of Fibrostenosis in Patients With Small Bowel Crohn's Disease
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.
Read more
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.
- Conditions
- Crohn's Disease, Intestinal Fibrosis, Inflamatory Bowel Disease, Intestinal Strictures Related to Crohn´s Disease
- Being tested
- Ga68-FAPI-46
- Keywords
- Ga68-FAPI-46, PET/CT, Small bowel stricture, Fibrostenosis, FAPI PET, Small bowel Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga68-FAPI-46Drug
Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV
| Study group | Role | What they receive |
|---|---|---|
| A group of participants getting PET/CT scan with 68Ga-FAPI-46 | Experimental | Ga68-FAPI-46 radioactive tracer binding to FAP Receives: Drug: Ga68-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of PET/CT with Ga68-FAPI-46 by all participants
Measured: Through study completion, an average of 2 years
Number of participants completing PET/CT with Ga68-FAPI-46
Participants complete PET/CT with Ga68-FAPI-46
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start26 Jan 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, David J. Bartlett, Mayo Clinic
- Investigators
- David J Bartlett, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273188
- Sponsor's protocol ID
- 25-008885
- Acronym
- FAPI-PETCD
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPI-46) PET in Crohn's Disease Patients: a Case-control Study Designed to Illuminate the Spectrum of Fibrostenosis in Patients With Small Bowel Crohn's Disease
- ClinicalTrials.gov ID
- NCT07273188
- Acronym / sponsor ID
- FAPI-PETCD / 25-008885
- Conditions
- Crohn's Disease, Intestinal Fibrosis, Inflamatory Bowel Disease, Intestinal Strictures Related to Crohn´s Disease
- Keywords
- Ga68-FAPI-46, PET/CT, Small bowel stricture, Fibrostenosis, FAPI PET, Small bowel Crohn's disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Dec 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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A group of participants getting PET/CT scan with 68Ga-FAPI-46 | Experimental | Drug: Ga68-FAPI-46Ga68-FAPI-46 radioactive tracer binding to FAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant and/or breast-feeding subjects.
- Hypersensitivity to any excipients in 68Ga-FAPI-46
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga68-FAPI-46Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV | Drug | A group of participants getting PET/CT scan with 68Ga-FAPI-46 |
Primary outcome
Completion of PET/CT with Ga68-FAPI-46 by all participants
Time frame: Through study completion, an average of 2 years
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
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 9 Feb 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.
David J Bartlett principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ga68-FAPI-46 in people with Crohn's Disease and Intestinal Fibrosis, run by Mayo Clinic at 1 site in United States.
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 6 inclusion and 2 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 9 Feb 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 States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Brian Will (507-266-0111, will.brian@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of PET/CT with Ga68-FAPI-46 by all participants (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 9 Feb 2026.