The primary objective is to assess the feasibility and accuracy of dynamic contrast enhanced MRI in diagnosing UC or CD in children as compared to endoscopy and abdominal ultrasound.The secondary objective is to assess the feasibility of dynamic…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the accuracy of diagnosing CD or UC with
dynamic contrast enhanced MR enterography and colonography as compared to upper
and lower tract endoscopy and abdominal ultrasound.
Secondary outcome
The secondary study parameters will be the comparison of DCE-MRI with
histopathological biopsies and Pedriatric Crohn*s Disease Activity Index en
Pediatric Ulcerative Colitis Activity Index scores for grading disease activity
in IBD patients.
Background summary
Inflammatory bowel disease (IBD) primarily comprises ulcerative colitis (UC)
and Crohn's disease (CD). These disorders have distinct pathologic and clinical
characteristics. Because there is a difference in treatment strategies and
clinical course of both diseases, it is important to establish the correct
diagnosis when a patient is suspected of IBD. This is done by a complete
work-up comprised of clinical history, physical examination, laboratory
studies, endoscopic findings, histological interpretation of mucosal biopsy
specimens and imaging studies. Magnetic resonance imaging (MRI) is used for
assessing disease activity of the small bowel. Abdominal MR-imaging using
luminal and intravenous contrast medium combines transmural and
extra-intestinal evaluation and can accurately show presence of disease.
Gadolinium is an extracellular contrast agent that rapidly passes from the
vasculature into the extravascular-extracellular space and in that way produces
parenchymal enhancement, which is associated with disease activity. Dynamic
contrast enhanced MRI (DCE-MRI) is a method to objectively determine the
enhancement after administration of intravenous contrast medium. In DCE-MRI
images are acquired during the delivery of contrast in the tissue of interest,
highlighting the dynamic response of the tissue to the inflow of blood.
Analysis of the time-dependent changes in signal intensity by DCE-MRI can
provide valuable information about disease activity. One recent study by
Horsthuis et al. has shown that DCE-MRI can be used to determine disease
activity in perianal fistulizing CD, as correlations were found between
clinically active disease and more quickly enhancing pixels, meaning a stronger
vascularisation, in patients with perianal fistulizing CD. We expect this also
to be the case in patients with active luminal CD and UC because in these
patients there is also an increased degree of vascularity in the bowel due to
the inflammatory reaction. We combine DCE-MRI enterography and colonography in
the same session to assess the enhancement of the bowel wall and thus give
objective measurements of disease activity thereby aiding in the diagnosis of
UC or CD in pediatric patients.
Study objective
The primary objective is to assess the feasibility and accuracy of dynamic
contrast enhanced MRI in diagnosing UC or CD in children as compared to
endoscopy and abdominal ultrasound.
The secondary objective is to assess the feasibility of dynamic contrast
enhanced MRI in grading disease activity in UC or CD in pediatric patients.
Study design
We want to conduct a prospective observational study. All patients with
clinical suspected IBD will undergo a MRI scan with oral and intravenous
contrast medium and gastroscopy and ileocolonoscopy under general anesthesia as
part of their clinical routine.
The Pediatric Crohn*s Disease activity index, and the Pediatric Ulcerative
Colitis activity index will be calculated at the outpatient clinics.
Study burden and risks
Patients will undergo an ileocolonoscopy and gastroscopy under general
anesthesia and MRI with oral and intravenous contrast medium scan as part of
their clinical investigation. For this study, an extra dynamic sequence will be
added to the MRI scan (scanning time will be prolonged for 10 minutes, total
scanning time will be 50 minutes).
For this preparation patients will be asked to come two hours earlier and drink
an additional contrast medium for the distension of the colon (400 ml extra) .
Also an additional abdominal utrasound will be performed on the same day or the
day before the endoscopy or the same day as the MRI scan so no additional visit
to the hospital is necessary. No extra preparation is required for the
ultrasound.
PB 22660
1100 DD
NL
PB 22660
1100 DD
NL
Listed location countries
Age
Inclusion criteria
Clinically suspected inflammatory bowel disease
Scheduled to undergo endoscopy
Scheduled to undergo MRI
Written Informed patients (>12 years of age) and parental consent
Exclusion criteria
Age < 8 and > 18 years
General contraindications for MRI (such as pregnancy, claustrophobia, renal insufficiency) or endoscopy
Lack of written informed consent
Inability to perform a 20 second breath hold
Inability to drink 800 ml of the oral contrast agent (Sorbitol).
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 |
---|---|
CCMO | NL31177.018.10 |