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ISRCTN
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ISRCTN55042368
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ClinicalTrials.gov identifier
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Public title
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Magnetic resonance imaging (MRI) fluoroscopy for imaging childhood gastrointestinal malrotation
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Scientific title
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Magnetic resonance imaging (MRI) replacement of x-ray fluoroscopy in paediatric imaging: an investigation of gastrointestinal malrotation
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Acronym
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N/A
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Serial number at source
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6144; G0800411
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Study hypothesis
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The aim of this study is to develop rapid magnetic resonance imaging (MRI) techniques which will replace X-ray fluoroscopy methodology for diagnostic imaging in children with suspected gastrointestinal abnormalities (e.g., gut malrotation).
This project has two parts:
1. We aim to optimise the MRI environmnet for small children, including patient handling, communication, nursing and parental support requirements, and refinement of MR protocols, with direct parent feedback.
2. We will then conduct a diagnostic performance trial; a non-randomised feasibility trial comparing the established X-ray investigation with the optimised MR investigation in children with suspected gut abnormalities, to ensure that MRI is as good, if no better than, X-ray testing.
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Lay summary
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Ethics approval
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Cambridgeshire 3 Research Ethics Committee approved on the 15th April 2008 (ref: 08/H0306/7)
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Study design
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Single centre non-randomised observational diagnosis and validation of investigative process trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Gastrointestinal, Paediatrics
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Participants - inclusion criteria
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1. All children between the ages of 0 and 6 years referred for an upper gut XRF contrast study for suspected upper intestinal obstruction, i.e., malrotation
2. Age range: 1 day to 6 years, male and female
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Participants - exclusion criteria
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1. Usual MR exclusion criteria will apply, but are highly unlikely in this young age group. They include pregnancy, claustrophobia, cardiac pacemakers, metallic implants, cardiac defibrillator implants, aneurysym clips or metallic heart valves, and cochlear or inner ear implants. These exclusion criteria would apply to all people within the vicinity of the MRI scanner, e.g., the parents/guardians in this study.
2. Previous reaction to the relevent X-ray or MRI contrast media (including gadolinium)
3. Congenital abnormalities that make X-ray fluoroscopy or MR fluoroscopy impractical
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Anticipated start date
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01/11/2008
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Anticipated end date
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01/09/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 50
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Interventions
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All patients volunteering for this study will undergo the conventional XR fluoroscopy examination as per standard practice, followed by an additional MRI examination.
The diagnosis of the XR test will be known, in order to select the patients most appropriate for MR examination. However, the MRI examination will be reported by a radiologist blinded to the diagnosis made on X-ray. As the presence or absence of gut malrotation is a stable diagnosis, the confirmation of its presence on the X-ray test is unlikely to affect the MRI test.
Data collection involves completion of demographic proformas, parent questionnaires, and real-time acquisition of radiological images which will be assessed and stored for retrospective analysis. The two examinations are expected to take place on the same day. The conventional X-ray studies will be reported immediately following normal practice to allow for immediate clinical management. In each case the person supervising and reporting the respective studies will not be aware of the results of the other investigation.
Upper gastrointestinal studies will be reported for the presence/absence of the duodeno-jejunal flexure in the correct anatomical location, and for any other duodenal or jejunal abnormalities.
There is no follow-up as part of the study, but patients will be treated as per standard practice on the basis of the XR fluoroscopy results.
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Primary outcome measure(s)
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Can a technique using magnetic resonance MR fluoroscopy be developed to replace the conventional X-ray fluoroscopy methodology?
All outcomes will be assessed at the time of the intervention.
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Secondary outcome measure(s)
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To demonstrate the feasability of magnetic resonance imaging for this type of paediatric imaging, including an assessment of its technical and diagnostic performance, by direct comparison with the established X-ray fluoroscopy based techniques. After each participant has their MRI scan, the results will be compared with those obtained with the standard x-ray fluoroscopy technique, and scored for sensitivity and accuracy in diagnosing gut malrotation.
All outcomes will be assessed at the time of the intervention.
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Sources of funding
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Medical Research Council Clinical Research Training Fellowship (MRC CRTF) (UK) - Royal College of Radiologists (ref: G0800411)
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Trial website
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Publications
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Contact name
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Ms
Wendy
Phillips
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Address
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Radiology, Box 162
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 0QQ
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Country
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United Kingdom
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Email
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wendyphillips@addenbrookes.nhs.uk
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Sponsor
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Cambridge University Hospitals NHS Foundation Trust (UK)
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Address
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Addenbrookes Hospital
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 0QQ
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Country
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United Kingdom
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Sponsor website:
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http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
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Date applied
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07/07/2010
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Last edited
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26/07/2010
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Date ISRCTN assigned
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07/07/2010
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