Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257498
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2024-01-23
Brief Title:
Upright Open MRI for Brain Imaging in Children - a Pilot Study
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
Upright Open MRI for Brain Imaging in Children - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Heads-Up
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
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 participants parents will be simultaneously recruited
Planned Size of Sample if applicable 20 young school-aged children 5 to 10 years referred for brain MRI at NUH The child participants parents will be simultaneously recruited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None