Helmsley 3.0: Abbreviated MRE

October 23, 2025 updated by: Children's Hospital Medical Center, Cincinnati

Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Jeff Fidler
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone
        • Contact:
        • Principal Investigator:
          • Bari Dane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children and adults

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare clinical MRE with research MRE
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.
Time Frame: 3 years
Patients/patients parents will answer a survey to determine if the abbreviated magnetic resonance enterography (MRE) or the clinical MRE is preferred.
3 years
Willingness to trade diagnostic performance for patient experience
Time Frame: 3 years
We will ask patients a series of questions to determine their tolerance for trading diagnostic performance for a better patient experience.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Jonathan Dillman, CCHMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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