Helmsley 3.0: Abbreviated MRE

Recruiting

• Conditions: Crohn's Disease
• Interventions: Diagnostic Test: Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)

• Registration Number: NCT06533228
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

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 Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Study Start: 2024-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Primary Completion: 2027-02-28
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's Disease Patients	Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)	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.

Primary Outcome Measures

Name	Time	Method
Compare clinical MRE with research MRE	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 Outcome Measures

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

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

NYU Langone; 🇺🇸 New York, New York, United States