Pilot Study on FDG PET/MRE for Stricture Assessment in Crohn’s Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-006956
Sponsor Protocol Number: 17-006956
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