Helmsley 3.0: Abbreviated MRE

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Crohn's Disease

Treatments: Diagnostic Test: Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)

Study type: Observational

Funder types: Other

Identifiers

NCT06533228

2024-0086

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Crohn's Disease Patients

Description:

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.

Treatment:

Diagnostic Test: Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)