Recruiting

MRE

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06533228

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Crohn's Disease

Study ID

NCT06533228

Start date

Sep 1, 2024

Status verified date

Oct, 2025

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Magnetic 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.

Primary outcome measure

  • Compare clinical MRE with research MRE [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Tanita Dean

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

Kristi Cole

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kristin Fritz

507-293-0925yaggy.Kristin@mayo.edu

Principal Investigator:

Jeff Fidler

NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Nalini Jeet

212-263-0228Nalini.Jeet@nyulangone.org

Principal Investigator:

Bari Dane

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-10-27.