Condition category
Surgery
Date applied
07/07/2010
Date assigned
07/07/2010
Last edited
28/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Wendy Phillips

ORCID ID

Contact details

Radiology
Box 162
Hills Road
Cambridge
CB2 0QQ
United Kingdom
wendyphillips@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6149

Study information

Scientific title

Magnetic resonance imaging (MRI) replacement of x-ray fluoroscopy in paediatric imaging: an investigation of vesicoureteric reflux

Acronym

Study hypothesis

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

Cambridgeshire 3 Research Ethics Committee, 26/06/2008, ref: 08/H0306/39

Study design

Single-centre non-randomised observational diagnosis and validation of investigative process trial

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned sample size: 50

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Radiology, Box 162
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes