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Dynamic MRI with mapping of T1-values as indicators of disease activity in luminal Crohn’s disease.


- candidate number7725
- NTR NumberNTR2200
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2010
- Secondary IDs08/139 MEC AMC
- Public TitleDynamic MRI with mapping of T1-values as indicators of disease activity in luminal Crohn’s disease.
- Scientific TitleDynamic MRI with mapping of T1-values as indicators of disease activity in luminal Crohn’s disease.
- ACRONYMDCE-MRI luminal CD
- hypothesisTo 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) studiedCrohn's disease
- Inclusion criteria1. 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 criteria1. Under 18 years of age;
2. General contraindications to MRI (claustrophobia, pregnancy, renal insufficiency, pacemakers).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-jun-2011
- Target number of participants30
- InterventionsLonger MRI scan due to extra dynamic sequence.
- Primary outcomeThe 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 outcomeThe secondary endpoints will be the comparison of DCE MRI with T1-mapping as compared to CDEIS, CRP, CDAI.
- TimepointsPatients will undergo the ileocolonoscopy and the MRI will be planned before or after.
- Trial web siteN/A
- statusstopped: 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
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Radiology
- PublicationsN/A
- Brief summaryCrohn’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.

Objective:
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.

Study design:
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.

Study population:
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)
- RECORD4-feb-2010 - 5-okt-2011


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