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

NCT06257498 | Completed

• 1 other identifier: 20DI001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

Upright open scanner; MRI; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Procedure: MRI scan

Interventions

MRI scan PROCEDURE

MRI scan on open scanner and some questionnaires

MRI upright open scanner

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Parent / carer of a child participant

You may not qualify if:

• 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).
• Contra-indication to being in the scan room

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 7720333 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.

  PMID: 25320001 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.

  PMID: 18084752 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.

  PMID: 20186541 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.

  PMID: 16884416 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Rob Dineen, prof

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 14, 2024
• Study Start: January 25, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)