Helmsley 3.0: Abbreviated MRE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2028-02-29

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No