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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Willingness to trade diagnostic performance for patient experience |
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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
Exclusion Criteria:
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Children and adults
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanita Dean | Contact | (513) 803-0853 | Tanita.Dean@cchmc.org | |
| Kristi Cole | Contact | (513)636-9403 | kristi.barnett@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Dillman | CCHMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2024 | Jun 28, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2024 | Jun 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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We will ask patients a series of questions to determine their tolerance for trading diagnostic performance for a better patient experience. |
| 3 years |
| NYU Langone | Recruiting | New York | New York | 10016 | United States |
|
| D007410 | Intestinal Diseases |