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RecruitingNCT06533228Updated Oct 27, 2025

Helmsley 3.0: Abbreviated MRE

An observational study in Crohn's Disease, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 2 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2025-10-27.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
10 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Crohn's Disease

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Keywords

  • Magnetic Resonance Imaging (MRI)
  • Crohn's Disease
  • Magnetic Resonance Enterography (MRE)
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 300 is above the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children and adults

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • Diagnostic testMagnetic 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.

06

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.

    Patients/patients parents will answer a survey to determine if the abbreviated magnetic resonance enterography (MRE) or the clinical MRE is preferred.

    Time frame: 3 years

  2. Willingness to trade diagnostic performance for patient experience

    We will ask patients a series of questions to determine their tolerance for trading diagnostic performance for a better patient experience.

    Time frame: 3 years

07

Study locations

2 of 2 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
  • NYU Langone
    New York, New York 10016, United States
    Recruiting
08

References and documents

Study documents

  • Study protocol · Apr 11, 2024
  • Informed consent form · Jun 17, 2024

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06533228
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Aug 1, 2024
Start date
Sep 1, 2024
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 27, 2025

Study contacts

Tanita Dean
Contact
Tanita.Dean@cchmc.org
(513) 803-0853
Kristi Cole
Contact
kristi.barnett@cchmc.org
(513)636-9403
Jonathan Dillman
principal investigator · CCHMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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