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

Brain Tumor Clinical Trial

— Heads-Up  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06257498
• Other study ID #: 20DI001
• Status: Completed
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: February 2024
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Procedure:
• MRI scan
MRI scan on open scanner and some questionnaires

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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