Upright Open MRI for Brain Imaging in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2023-03-10

Brief Summary

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PRIMARY OBJECTIVE To establish feasibility and acceptability of diagnostic brain MRI in young children for specified indications using an upright MRI system without sedation or anaesthesia.

SECONDARY OBJECTIVES To establish how young children who undergo brain MRI using upright MRI view the experience To establish how parents / carers of young children who undergo brain MRI using the upright MRI view the experience for their child and for themselves.

To establish how image quality compares between brain MRI using the upright MRI scanner and the standard MRI scanner used in clinical practice.

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Detailed Description

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Study Design Feasibility study collecting data on image quality and experience of upright open MRI scanning (performed in addition to standard clinical MRI scan), and comparing outcome measures to standard supine MRI scans, in children referred for clinical MRI scanning for (i) symptoms or signs suggestive of brain tumour and (ii) symptoms or signs suggestive of shunt blockage in children with a ventriculoperitoneal (VP) shunt Study Participants Participants that have been referred for brain MRI for symptoms and signs suggestive of brain tumour or who have known VP shunts with a clinical suspicion of shunt dysfunction. 20 participants in total, aiming for an even split between these two groups but will be flexible based on the local clinical case load.

Planned Size of Sample (if applicable) 20 young school-aged children (5 to 10 years) referred for brain MRI at NUH. The child participant's parents will be simultaneously recruited

Conditions

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Brain Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI upright open scanner

All participants will undergo MRI scanning in the dedicated open upright 0.5T MRI research MRI scanner , with parents or guardian in attendance if desired, and with their own choice of music or video during the scan.

Immediately following the MRI scan we will collect information relating to their experience of the upright scanner using an age-appropriate questionnaire, based on similar questionnaires that we have used for paediatric MRI studies previously. A photograph of the upright MRI room will be used to prompt this discussion. The parent or carer may also be involved in prompting the child's responses.

We will also collect the views of the parent / carer using a questionnaire.

Group Type OTHER

MRI scan

Intervention Type PROCEDURE

MRI scan on open scanner and some questionnaires

Interventions

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MRI scan

MRI scan on open scanner and some questionnaires

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Referred for clinical brain MRI scan for either:

Symptoms and signs suggestive of brain tumour, or Known VP shunts with a clinical suspicion of shunt dysfunction Parental consent and child's agreement to participate

Parent / carer of a child participant

Exclusion Criteria

* Contra-indication to MRI scans Programmable VP shunt requiring re-programming after the research MRI Unable to sit upright unsupported Focal intracranial signs such that a targeted MRI protocol would be required (e.g. focal seizures, focal neurology, visual impairment, pituitary dysfunction).

Contra-indication to being in the scan room

Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No