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ISRCTN
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ISRCTN98320102
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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 vesicoureteric reflux
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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 vesicoureteric reflux
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Acronym
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N/A
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Serial number at source
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6149
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Study hypothesis
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X-ray fluoroscopy is widely used for diagnosing suspected serious childhood abnormalities such as urinary tract abnormalities, despite the induced solid malignancy risk secondary to ionising radiation exposure. Magnetic resonance imaging (MRI) is considered safer than X-rays, but fluoroscopy-like MRI techniques have not yet been developed for paediatric applications, where the avoidance of ionising radiation would be of great benefit. Development requires the integration and adaptation of MR technologies to support the study of small children in the relatively hostile environment of an MR system, and evidence that similar results to X-ray fluoroscopy are achievable.
Aims:
1. To develop robust MR applications based on recently developed MR technology for childhood abnormalities of the renal tract (vesico-ureteric reflux and posterior urethral valves).
2. To evaluate the technical and diagnostic performance of the MR technique by direct comparison with the established X-ray fluoroscopy based techniques.
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Ethics approval
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Cambridgeshire 3 Research Ethics Committee approved on the 26th June 2008 (ref: 08/H0306/39)
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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: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics
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Participants - inclusion criteria
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1. All children (usually boys) between the ages of 0 and 3 years referred for direct micturating cysto-urethrography (MCUG)
2. All children with hydronephrosis diagnosed antenatally on foetal ultrasound
3. Age range: 0 days - 3 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 age group. The 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 clearly apply to all people within the vicienity of the MRI scanner, and therefore apply equally to the parents/guardians in this study.
2. Previous reaction to the relevant x-ray or MRI contrast medium (including gadolinium)
3. Congenital abnormalities that make X-ray fluoroscopy of MR fluoroscopy impractical
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Anticipated start date
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01/09/2008
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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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Ongoing |
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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 conventional XR fluoroscopy as per standard care, followed by an additional MRI examination. 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 within 24 hours of each other. The conventional X-ray studies will be reported immediately following normal practice and allowing for clinical management and decision making. Both the XR and MRI studies will be reported for the presence/absence of posterior urethral ballooning during voiding and the presence and grade of any VUR using the conventional established grading scheme. In each case the person supervising and reporting the respective studies will not be aware of the results of the other investigation.
There is no follow-up as part of this study, but patients will be treated as per standard care on the basis of the results from their XR fluoroscopy examination.
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Primary outcome measure(s)
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The ability of the MR fluoroscopy examination to accurately detect:
1. Significant grade VUR likely to alter clinical management
2. The presence of posterior urethral ballooning
Assessed at the time of the intervention
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Secondary outcome measure(s)
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Assessed at the time of the intervention:
1. Image quality
2. Artifacts
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme
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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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