Upright Open MRI for Brain Imaging in Children - a Pilot Study
- Conditions
- Brain Tumor
- Interventions
- Procedure: MRI scan
- Registration Number
- NCT06257498
- Lead Sponsor
- Nottingham University Hospitals NHS Trust
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRI upright open scanner MRI scan 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.
- Primary Outcome Measures
Name Time Method MRI scan feasibility and image quality rating (by neuroradiologists) . 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 Outcome Measures
Name Time Method Scan acceptability - patient /Carer questionaire before and after each scan. 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'.
Scan acceptability- child questionnaires before and after each scan 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'.
Trial Locations
- Locations (1)
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Nottingham University Hospitals NHS Trust🇬🇧Nottingham, Nottinghamshire, United Kingdom