Crohn's disease regional enteritis
Conditions
Interventions
None listed
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is *gain of enhancement'' of affected intestinal segment(s) on MRE and histopathology of the corresponding segment(s), surgically resected, as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| The technical outcome measures for this study are as follows: * Measuring MRE image quality, as specified in the imaging review charter * Measuring compliance with the MRE technical protocol for patient preparation and scanning, as specified in the imaging review charter The secondary outcome measure is the MT ratio of affected intestinal segment(s) on MRE. Safety Outcome Measures The safety outcome measures for this study are as follows: * Incidence, nature, and severity of adverse events (assessed and graded according to the grading criteria in Sections 5.3.3 and 5.3.4) The exploratory outcome measures for this study are as follows: * Serum, plasma, PAXgene blood RNA, and tissue biomarkers for inflammation and fibrosis * MRE evaluation of wall thickness, edema, ulceration, pattern and time of enhancement of the affected segment(s), and global and per-segment Magnetic Resonance Index of Activity (MaRIA) scores (Rimola et al. 2009) * Apparent diffusion coefficient of affected intestinal segment(s) on MRE (Tielbeek et al. 2013) | — |
Countries
Netherlands
Outcome results
None listed