Helmsley 3.0: Abbreviated MRE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE).
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease
Overview
The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.
Detailed description
This multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with Crohn's Disease.
The abbreviated MRI of the bowel or MRE will not involve IV contrast or an injection of glucagon and water will replace the oral contrast used in standard of care MREs. Scan time will be greatly reduced with the abbreviated MRE ( approximately 15 minutes) compared to a standard of care MRE (approximately 60 minutes).
Interventions
- Diagnostic test Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)
Abbreviated magnetic resonance enterography (MRE) imaging to detect active inflammation in patient's with known Crohn's Disease.
Primary outcome measures
- Compare clinical MRE with research MRE [Time frame: 3 years]
Secondary outcome measures (2)
- Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE. [Time frame: 3 years]
- Willingness to trade diagnostic performance for patient experience [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Established Crohn's disease diagnosis in patients 10 and older
- Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below
- Staging/ restaging/ follow- up of intestinal inflammation
- Evaluation of known or suspected luminal narrowing/ stricturing disease
- Evaluation of known or suspected internal penetrating disease
Exclusion criteria
- Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established
- New Crohn's disease diagnosis, undergoing baseline imaging
- Isolated colonic disease
- Known or suspected pregnancy
- Contraindication to magnetic resonance imaging (MRI)
- Ileostomy or prior ileal resection
- Less than 10 years of age
- Unable or unwilling to follow imaging procedures
- Non- English speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Mayo Clinic — Rochester
- NYU Langone — New York
Identifiers
NCT: NCT06533228 · 2024-0086