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NCT Number: NCT06533228

Helmsley 3.0: Abbreviated MRE

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.

Recruiting

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)

Diagnostic Test

Abbreviated magnetic resonance enterography (MRE) imaging to detect active inflammation in patient's with known Crohn's Disease.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristi Cole

CONTACT

[email protected]

(513)636-9403

Tanita Dean

CONTACT

[email protected]

(513) 803-0853

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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