STRICTuring Crohn’s disease assessment using advanced Ultrasound and magnetic REsonance imaging techniques for evaluation of inflammation and fibrosis
- Conditions
- Crohn's Disease
- Registration Number
- NL-OMON24793
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
•Endoscopic or histological confirmed Crohn’s Disease
•Age = 18 year
•One or more small bowel stricture(s) confirmed on endoscopy and/or cross-sectional imaging
•Scheduled for anti-inflammatory treatment or surgery
•Isolated colonic stricture
•Endoscopic balloon dilation prior to baseline MRI or ultrasonography
•Pregnancy
•Age <18years
•Inability to give informed consent
•Ongoing gastroenteritis
•No stricture visible on ultrasound and/or MRI
•Specifically for MRI
oGeneral contraindications for MRI (MRI-incompatible implants, pacemaker, claustrophobia, and pregnancy)
•Specifically for CEUS
oChronic obstructive lung disease
oAcute coronary heart disease
oClinically unstable heart disease
oPrevious allergic reaction to Sonovue or to its components
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI:<br>-MT-ratio<br>-IVIM fractional perfusion<br>-T2*-value<br>-Quantitated intestinal motility<br>Ultrasound:<br>-Speed of velocity of shear-wave (m/s)<br>-Mean transit time of intravascular contrast (s)<br>-Time to peak (s)<br>-Blood volume per tissue (mL/100 mL tissue)<br>-Blood flow (m/s)<br>-Time between arrival of oral contrast at the stricture and passage through the stricture<br>-Number of bowel movements before oral contrast passes through the stricture<br>Clinical:<br>-Response to therapy after 26 weeks of treatment (defined by the continuation of baseline medical therapy without adding other anti-inflammatory medication, the absence of the need for an intervention (balloon dilation or surgery) and no clinical deterioration based on clinical activity indices9,31)<br>Histopathology:<br>-Inflammation grades<br>-Fibrosis grades<br>
- Secondary Outcome Measures
Name Time Method -Conventional MRI parameters: length of the stricture, prestenotic dilatation, bowel wall thickness, bowel wall edema, bowel wall enhancement and stratification, fatty wrapping, presence of lymph nodes, fistulas and abscesses.<br>-Conventional ultrasound parameters: length of the stricture, prestenotic dilation, bowel wall thickness, wall layer stratification, fatty wrapping, Doppler signal, motility, presence of lymph nodes, abscesses, fistulas.<br>-Clinical information: medical history, sex, age, weight, height, current and previous medication<br>-Clinical activity scores: Harvey-Bradshaw Index31 (HBI) and Crohn’s Disease Obstructive Score9 (CDOS)<br>-Blood: C-reactive protein, hemoglobin, platelet count, leukocyte count, erythrocyte count and albumin<br>-Faecal calprotectin<br>