Magnetic resonance imaging (MRI) fluoroscopy for imaging childhood vesicoureteric reflux

ISRCTN	ISRCTN98320102
DOI	https://doi.org/10.1186/ISRCTN98320102
Secondary identifying numbers	6149

Submission date: 07/07/2010
Registration date: 07/07/2010
Last edited: 27/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Wendy Phillips
Scientific

Radiology, Box 162
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Email	wendyphillips@addenbrookes.nhs.uk

Study information

Study design	Single-centre non-randomised observational diagnosis and validation of investigative process trial
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Magnetic resonance imaging (MRI) replacement of x-ray fluoroscopy in paediatric imaging: an investigation of vesicoureteric reflux
Study objectives	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 (vesicoureteric 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.
Ethics approval(s)	Cambridgeshire 3 Research Ethics Committee, 26/06/2008, ref: 08/H0306/39
Health condition(s) or problem(s) studied	Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics
Intervention	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.
Intervention type	Procedure/Surgery
Primary outcome measure	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
Secondary outcome measures	Assessed at the time of the intervention: 1. Image quality 2. Artifacts
Overall study start date	01/09/2008
Completion date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	0 Years
Upper age limit	3 Years
Sex	Both
Target number of participants	Planned sample size: 50
Key inclusion criteria	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
Key exclusion criteria	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, aneurysm clips or metallic heart valves, and cochlear or inner ear implants. These exclusion criteria clearly apply to all people within the vicinity 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
Date of first enrolment	01/09/2008
Date of final enrolment	01/09/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrookes Hospital

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Wendy Phillips (wendyphillips@addenbrookes.nhs.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2013		Yes	No

Editorial Notes

27/07/2017: IPD sharing statement added.
28/04/2017: Publication reference added.