Helmsley 3.0: Abbreviated MRE

Children's Hospital Medical Center, Cincinnati300 enrolled

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.

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

300

Conditions

Crohn's Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

NYU Langone

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Tanita Dean

CONTACT

(513) 803-0853 Tanita.Dean@cchmc.org

Kristi Cole

CONTACT

(513)636-9403 kristi.barnett@cchmc.org

Data from ClinicalTrials.gov

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