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NCT Number: NCT07273188

68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ga68-FAPI-46

Drug

Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV

Primary outcomes

  1. Completion of PET/CT with Ga68-FAPI-46 by all participants

    Time frame: Through study completion, an average of 2 years

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Will

CONTACT

[email protected]

507-266-0111

Yong S Lee

CONTACT

[email protected]

507-538-4446

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Official study 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

Acronym: FAPI-PETCD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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