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

6144; G0800411

Study information

Scientific title

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

Acronym

Study hypothesis

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 environment 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 not better than, X-ray testing.

Ethics approval

Cambridgeshire 3 Research Ethics Committee, 15/04/2008, ref: 08/H0306/7

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: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Gastrointestinal, Paediatrics

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

To demonstrate the feasibility 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.

Overall trial start date

01/11/2008

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

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

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 young age group. They 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 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 relevant X-ray or MRI contrast media (including gadolinium)
3. Congenital abnormalities that make X-ray fluoroscopy or MR fluoroscopy impractical

Recruitment start date

01/11/2008

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

Research council

Funder name

Medical Research Council Clinical Research Training Fellowship (MRC CRTF) (UK) - Royal College of Radiologists (ref: G0800411)

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