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Completed

NCT Number: NCT06257498

Upright Open MRI for Brain Imaging in Children - a Pilot Study

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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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

for the adult participants:

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).

Exclusion criteria

for the adult participants:

Contra-indication to being in the scan room

Treatment and study plan

MRI scan

Procedure

MRI scan on open scanner and some questionnaires

Primary outcomes

  1. MRI scan feasibility and image quality rating (by neuroradiologists) .

    Time frame: within 4 weeks of diagnostic MRI scan

    To establish feasibility and acceptability of diagnostic brain MRI in young children for specified indications using an upright MRI system without sedation or anaesthesia. Two experienced neuroradiologists blinded to patient and scanner will assess image quantity and motion artifact on each scan and rating image quality on a five point likert scale.Exams classified as 3, 4, or 5 "good", "very good" and " excellent" are considered diagnostic. The primary acceptability endpoint is defined as: 'more than 75% of child participants reporting a positive experience of the upright open MRI scan'.

Secondary outcomes

  1. Scan acceptability- child questionnaires before and after each scan

    Time frame: all the questionnaires will be completed on the study day visit for the research scan, this will be within four weeks of the diagnostic clinical scan

    To establish how young children who undergo brain MRI using upright MRI view the experience using age appropriate questionaires.The primary acceptability endpoint is defined as: 'more than 75% of child participants reporting a positive experience of the upright open MRI scan'.

  2. Scan acceptability - patient /Carer questionaire before and after each scan.

    Time frame: all the questionnaires will be completed on the study day visit for the research scan, this will be within four weeks of the diagnostic clinical scan

    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 using questionaires. The primary acceptability endpoint is defined as: 'more than 75% of participants reporting a positive experience for their child of the upright open MRI scan'.

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Acronym: Heads-Up

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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