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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI upright open scanner | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI scan | Procedure | MRI scan on open scanner and some questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI scan feasibility and image quality rating (by neuroradiologists) . | 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'. | within 4 weeks of diagnostic MRI scan |
| Measure | Description | Time Frame |
|---|---|---|
| Scan acceptability- child questionnaires before and after each 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'. | 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 |
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Inclusion Criteria:
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:
Exclusion criteria for the adult participants:
Contra-indication to being in the scan room
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| Name | Affiliation | Role |
|---|---|---|
| Rob Dineen, prof | Nottingham University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7720333 | Background | Marshall SP, Smith MS, Weinberger E. Perceived anxiety of pediatric patients to magnetic resonance. Clin Pediatr (Phila). 1995 Jan;34(1):59-60. doi: 10.1177/000992289503400114. No abstract available. | |
| 25320001 | Background | Chou IJ, Tench CR, Gowland P, Jaspan T, Dineen RA, Evangelou N, Abdel-Fahim R, Whitehouse WP, Constantinescu CS. Subjective discomfort in children receiving 3 T MRI and experienced adults' perspective on children's tolerability of 7 T: a cross-sectional questionnaire survey. BMJ Open. 2014 Oct 15;4(10):e006094. doi: 10.1136/bmjopen-2014-006094. |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Scan acceptability - patient /Carer questionaire before and after each 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'. | 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 |
| 18084752 | Background | 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. |
| 20186541 | Background | 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. |
| 16884416 | Background | 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. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |