|- candidate number||6384|
|- NTR Number||NTR1986|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-sep-2009|
|- Secondary IDs||08/116 METC Academic medical center|
|- Public Title||Evaluatie van dynamische MRI als voorspeller van respons op behandeling in patienten met perianale fistels bij de ziekte van Crohn.|
|- Scientific Title||Evaluation of the predictive value of Dynamic MRI in determining treatment response in perianal fistulizing Crohn’s disease before and after treatment.|
|- hypothesis||To study whether dynamic MRI can predict treatment response and long term outcome in patients with Crohn’s disease. |
|- Healt Condition(s) or Problem(s) studied||Crohn's disease, Perianal fistula|
|- Inclusion criteria||1. Crohn's disease;|
2. Draining perianal fistula;
3. Starting with therapy for perianal fistula.
|- Exclusion criteria||1. Age < 18 years;|
2. Contraindications for MRI (pregnancy, renal insufficiency, allergy to contrast media, metallic implants).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||7-jul-2008|
|- planned closingdate||1-dec-2010|
|- Target number of participants||33|
|- Interventions||MRI before start therapy, after 12 weeks, after one year.|
|- Primary outcome||Predictive value of DCE-MRI before treatment and during treatment (12 weeks) in predicting or identifying early response as compared to the PDAI (12 weeks). |
|- Secondary outcome||Predictive value of DCE-MRI compared to the MRI-based score, CRP.|
|- Timepoints||1. Before therapy (week 0): DCE-MRI, PDAI (question list) and CRP (laboratory value);|
2. Week 12 after starting therapy: DCE-MRI, PDAI and CRP. One year after therapy: DCE-MRI and PDAI.
|- 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||Background: |
Crohn's disease (CD) is an inflammatory bowel disease (IBD). Perianal fistulas are reported to occur in up to 38% of patients. MR imaging is an effective imaging modality in the evaluation of patients with perianal CD as it can accurately demonstrate localization and extent of disease including clinically undetected fistula or abscess. Many patients with perianal Crohn's disease are treated with medicinal therapy. Clinical evaluation is inaccurate in determining treatment response. Initial studies have shown the potential of MRI in establishing the presence or absence of treatment response.
A recent study from our center (MEC number 04/271) has shown that dynamic contrast-enhanced MRI (DCE-MRI) before treatment can possibly add valuable, objective information about disease activity in perianal CD.
To study whether dynamic MRI can predict treatment response and long term outcome in patients with Crohn's disease.
Prospective observational study. We will study a cohort of consecutive patients with perianal Crohn's disease with DCE-MRI before and two times after remission induction therapy.
Adult patients visiting the AMC IBD outpatients' clinic with proven CD and a draining perianal fistula.
Main study parameters/endpoints:
The main study endpoint will be the predictive value of DCE-MRI compared to PDAI.
Patients participating will undergo a MRI scan 3 times; which is a routine procedure in these patients. For this study a 5 minute additional MRI sequence will be performed during each MRI scan. Also patients have to give one additional venous blood sample and fill in the PDAI, a questionnaire, three times.
|- Main changes (audit trail)|
|- RECORD||1-sep-2009 - 5-okt-2011|