Pilot Study on FDG PET/MRE for Stricture Assessment in Crohn’s Disease

Overview

About this study

Evaluation of TOF FDG PET-MRE for identification of predominantly fibrotic small bowel strictures in Crohn’s disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • CD subjects with symptoms that are attributed by the referring provider to intestinal strictures based on clinical assessment and/or unequivocal enteric luminal narrowing with or without proximal enteric dilatation on cross-sectional imaging (CT or MRI).
  • Subjects who are expected to undergo surgical resection of the intestinal strictures.
  • Male or female with age greater than 18 years old.
  • Subjects with the capacity to give informed consent and willingness to provide a written consent.

Exclusion Criteria

  • Subjects requiring emergent surgery for enteric strictures.
  • Blood glucose of greater than or equal to 200mg/dL at the time of PET/MRE or if a subject is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to FDG injection, subjects with blood glucose ≥ 200 mg/dL may participate in the study.
  • Pregnant and/or breast feeding subjects.
  • Subject weighing more than the allowable PET/MRE scanner weight limit (245kg).
  • Subjects with contraindication to MRI including:
    • Subjects who have a heart pacemaker.
    • Subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain.
    • Subjects who have implanted devices with magnets.
    • Subjects who have other implanted electronic devices.
    • Subjects who have deep brain stimulator.
    • Subjects who have vagal nerve stimulator.
    • Subjects with cochlear (ear) or auditory implants
  • Subjects with history of allergic response to radiocontrast media
  • Subjects with known history of claustrophobia.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Ajit Goenka, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20398311

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