Clinical trial NCT06257498: Upright Open MRI for Brain Imaging in Children - a Pilot Study
Official title: Upright Open MRI for Brain Imaging in Children - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Keywords: Upright open scanner
MRI
Magnetic Resonance Imaging
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 9
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: MRI scan feasibility and image quality rating (by neuroradiologists) .
timeFrame: within 4 weeks of diagnostic MRI scan
Secondary outcomes:
measure: Scan acceptability- child questionnaires before and after each scan
timeFrame: 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
measure: Scan acceptability - patient /Carer questionaire before and after each scan.
timeFrame: 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
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Rob Dineen, prof
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hallowell LM, Stewart SE, de Amorim E Silva CT, Ditchfield MR. Reviewing the process of preparing children for MRI. Pediatr Radiol. 2008 Mar;38(3):271-9. doi: 10.1007/s00247-007-0704-x. Epub 2007 Dec 15.
citation: Carter AJ, Greer ML, Gray SE, Ware RS. Mock MRI: reducing the need for anaesthesia in children. Pediatr Radiol. 2010 Aug;40(8):1368-74. doi: 10.1007/s00247-010-1554-5. Epub 2010 Feb 26.
citation: de Amorim e Silva CJ, Mackenzie A, Hallowell LM, Stewart SE, Ditchfield MR. Practice MRI: reducing the need for sedation and general anaesthesia in children undergoing MRI. Australas Radiol. 2006 Aug;50(4):319-23. doi: 10.1111/j.1440-1673.2006.01590.x.