|- candidate number||7725|
|- NTR Number||NTR2200|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-feb-2010|
|- Secondary IDs||08/139 MEC AMC|
|- Public Title||Dynamic MRI with mapping of T1-values as indicators of disease activity in luminal Crohn’s disease.|
|- Scientific Title||Dynamic MRI with mapping of T1-values as indicators of disease activity in luminal Crohn’s disease.|
|- ACRONYM||DCE-MRI luminal CD|
|- hypothesis||To test the accuracy of dynamic MRI with T1 mapping in patients with CD and compare this with know parameters such as CDEIS, CRP and CDAI.|
|- Healt Condition(s) or Problem(s) studied||Crohn's disease|
|- Inclusion criteria||1. Proven Crohn’s disease (by endoscopy or histopathology); |
2. Scheduled to undergo an ileocolonoscopy as part of their clinical follow-up;
3. Scheduled to undergo a MRI.
|- Exclusion criteria||1. Under 18 years of age;|
2. General contraindications to MRI (claustrophobia, pregnancy, renal insufficiency, pacemakers).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2009|
|- planned closingdate||1-jun-2011|
|- Target number of participants||30|
|- Interventions||Longer MRI scan due to extra dynamic sequence.|
|- Primary outcome||The main study parameter will be the accuracy of detecting disease activity and efficacy of DCE MRI with T1 mapping at MR in patients with proven Crohn’s disease as compared to ileocolonoscopy with histopathology.|
|- Secondary outcome||The secondary endpoints will be the comparison of DCE MRI with T1-mapping as compared to CDEIS, CRP, CDAI.|
|- Timepoints||Patients will undergo the ileocolonoscopy and the MRI will be planned before or after.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| M.L.W. Ziech|
|- CONTACT for SCIENTIFIC QUERIES|| M.L.W. Ziech|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Radiology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Radiology|
|- Brief summary||Crohn’s disease (CD) is a transmural inflammatory bowel disease. Grading of severity of disease is important to be able to optimally determine treatment strategy and response to treatment. Abdominal MR-imaging using luminal and intravenous contrast medium combines transmural and extra-intestinal evaluation and can accurately show presence of disease. |
The marked increase in signal intensity of inflammatory on contrast-enhanced fat saturated T1-weighted sequences can be seen due to increased tissue perfusion and vascular permeability. Analysis of the time-dependent changes of signal intensity after administration of contrast medium by DCE-MRI can add valuable information about disease activity in Crohn’s disease as the kinetic of the signal variation reflects the status of tissue microcirculation.
Hypothetically, calculation of the absolute T1-values in tissue before and after intravenous injection of Gadolinium would provide objective measurements of the Gadolinium-uptake. This so-called T1-mapping in abdominal MRI could indeed be used to determine activity of disease in an objective, quantifiable, reproducible manner and could be a valuable tool to the present imperfect disease scores such as CDAI (Crohn’s Disease Activity Index), CDEIS and CRP.
To test the accuracy of dynamic MRI with T1 mapping in patients with CD and compare this with know parameters such as CDEIS, CRP and CDAI.
A prospective observational feasibility study. Patients will undergo the clinically planned ileocolonoscopy, a MRI scan, and fill out the PDAI and a standardized questionnaire to score the burden of both tests.
Thirty patients with proven Crohn’s disease (by endoscopy and/or histopathology) who are scheduled to undergo ileocolonoscopy as part of their clinical follow-up will be included.
|- Main changes (audit trail)|
|- RECORD||4-feb-2010 - 5-okt-2011|