No registrations found.
ID
Source
Brief title
Health condition
Crohn, perianal fistula, perianale fistel.
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Objective:
To study whether dynamic MRI can predict treatment response and long term outcome in patients with Crohn's disease.
Study design:
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.
Study population:
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.
Study objective
To study whether dynamic MRI can predict treatment response and long term outcome in patients with Crohn’s disease.
Study design
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.
Intervention
MRI before start therapy, after 12 weeks, after one year.
M.L.W. Ziech
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663740
m.l.ziech@amc.uva.nl
M.L.W. Ziech
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663740
m.l.ziech@amc.uva.nl
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1872 |
NTR-old | NTR1986 |
Other | METC Academic medical center : 08/116 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |