Helmsley 3.0: Abbreviated MRE
Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease
1 other identifier
observational
300
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
October 27, 2025
October 1, 2025
2.5 years
July 25, 2024
October 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare clinical MRE with research MRE
Our abbreviated magnetic resonance enterography (MRE) will be non-inferior to a standard clinical MRE in detecting small bowel inflammation, strictures and penetrating disease associated with Crohn's Disease.
3 years
Secondary Outcomes (2)
Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.
3 years
Willingness to trade diagnostic performance for patient experience
3 years
Study Arms (1)
Crohn's Disease Patients
Children and adults, who are scheduled for a clinical magnetic resonance enterography (MRE) to evaluate staging/ restaging of Crohn's disease, will be approached to undergo our novel abbreviated MRE. No intervention, observation only, perform MRE, and complete trade-off tolerance survey.
Interventions
Abbreviated magnetic resonance enterography (MRE) imaging to detect active inflammation in patient's with known Crohn's Disease.
Eligibility Criteria
Children and adults
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55905, United States
NYU Langone
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Dillman
CCHMC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
August 1, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
October 27, 2025
Record last verified: 2025-10