|- candidate number||7728|
|- NTR Number||NTR2201|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-feb-2010|
|- Secondary IDs||08/348 MEC AMC|
|- Public Title||EVALUATION OF DYNAMIC MRI WITH T1-MAPS CORRELATED WITH HISTOPATHOLOGY IN PATIENTS WITH CROHN'S DISEASE.|
|- Scientific Title||EVALUATION OF DYNAMIC MRI WITH T1-MAPS CORRELATED WITH HISTOPATHOLOGY IN PATIENTS WITH CROHN'S DISEASE.|
|- ACRONYM||DCE-MRI correlation with PA in CD|
|- hypothesis||To determine the correlation between enhancement curves at DCE-MRI with T1-map and the level of histopathological activity. |
|- 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 small-bowel surgery for Crohn's Disease.];
3. Scheduled to undergo a preoperative MRI.
|- Exclusion criteria||1. Age < 18 years;|
2. General contraindications for MRI (pacemaker, claustrophobia, renal insufficiency and pregnancy).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-dec-2008|
|- planned closingdate||1-dec-2010|
|- Target number of participants||20|
|- Interventions||Preoperative MRI with extra dynamic sequence.|
|- Primary outcome||The main study parameter will be the accuracy of detecting disease activity and efficacy of DCE MRI at MR in patients with proven Crohn’s disease as compared to histopathology.|
|- Secondary outcome||The secondary study parameters will be the accuracy of detecting disease activity on DCE-MRI as compared to CDAI and CRP. Also the aspect of the bowel wall (serositis or normal) as seen during surgery will be compared to the MRI and the histology.|
|- Timepoints||Before surgery, the patient will undergo an abominal MRI.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- 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||Rationale: |
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. Moreover, MRI can discriminate between active and fibrotic disease as MRI studies undertaken to determine CD activity in the small and large bowel have indicated that a pathological increase in bowel wall enhancement after intravenous contrast administration of Gadolinium is a useful discriminatory sign of active disease.
Earlier studies have shown that dynamic contrast enhancement curves shown a correlation with active disease in patients with Crohn's disease related perianal fistulas. We expect this also to be the case in luminal Crohn's disease.
To determine the correlation between enhancement curves at DCE-MRI and the level of histopathological activity in patients with active luminal CD.
Prospective observational study. Patients will undergo a venapuncture and MRI scan as part of clinical routine before surgery. For this study, a dynamic sequence (DCE-MRI) sequence will be made during the MRI scan; therefore the scanning time will be prolonged for 15 minutes. Total scanning time will be 50 minutes. Also, patients have to fill in 1 questionnaire, the CDAI (duration less than 5 minutes). After surgery the resected bowel will be scanned in the MRI for anatomical reference. The inclusion period of the study will be 2 years.
Twenty adult patients with proven Crohn’s disease who are scheduled to undergo small-bowel surgery for active M. Crohn will be included after informed consent.
|- Main changes (audit trail)|
|- RECORD||4-feb-2010 - 17-feb-2010|