A prospective multicenter study to characterize magnetic resonance enterography assays for assessment of fibrosis in patients with Crohn's disease

Completed

• Conditions: Crohn's disease; regional enteritis; 10017969

• Registration Number: NL-OMON40715
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Patients must meet the following criteria for study entry:
*Signed Informed Consent Form
*Age 18 years of age or above
*Able to comply with the study protocol, in the investigator*s judgment
*Undergoing elective surgery for resection of medically refractory CD and/or presumed fibrostenotic or perforating disease
*Doses of CD medications must be stable from the time after MRE scan until surgery is performed.
*Estimated GFR within local institutional cut-off limits for the safe use of MRE and IV contrast agents

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study entry:
*Pregnant or lactating, or intending to become pregnant during the study
*Women who are not postmenopausal (at least 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative urine pregnancy test result before the MRE scan. Pregnancy tests at screening or before surgery should be performed as per institutional standard of care for patients undergoing elective surgery.
*Require emergency surgery for peritonitis or bowel obstruction
*Inability to comply with study protocol
*Poor peripheral venous access
*Contraindications to magnetic resonance imaging (MRI), including non MRI compatible medical or dental implants, other ferromagnetic metal objects in the body, severe claustrophobia, very large tattoos, inability to lie still in a supine position for up to 40 minutes, or inability to meet local imaging site MRI eligibility requirements based on safety screening assessments
*Significant uncontrolled disease, such as cardiac, pulmonary, renal, hepatic, endocrine, neurological, gastrointestinal, or hematologic disorders, that would contraindicate MRE scan or surgery
*History of severe allergic, anaphylactic, or other hypersensitivity reactions to gadolinium-based contrast agents

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is *gain of enhancement'' of affected intestinal<br /><br>segment(s) on MRE and histopathology of the corresponding segment(s),<br /><br>surgically resected, as the reference standard.</p><br>