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OpenTrials
Completed

NCT Number: NCT03471026

Advanced MRI for Posterior Fossa Tumours

Post-operative paediatric cerebellar mutism syndrome (pCMS) is a well-recognised complication of resective surgery for brain tumours of the cerebellum and fourth ventricle in children. Occurring in around 25% of infratentorial craniotomies, it is characterised by a delayed onset of mutism and emotional lability, and may comprise motoric and cognitive cerebellar deficits. Transient mutism gives way to prolonged, and often incomplete, recovery. Neuroimaging studies are beginning to reveal anatomical and functional aberrancies in the brain of children with pCMS. The cerebellar efferent pathways are likely to be implicated as a neuroanatomical substrate in the development of pCMS, as shown by a handful of diffusion tractography studies to date. However, the pathophysiology of this condition still remains unclear. Hypoperfusion of supratentorial cortical and subcortical structures may mediate the speech and behavioural deficits seen in pCMS, and is a candidate for a causal pathophysiological mechanism.

This study aims to prospectively image children with pCMS using advanced MRI techniques including diffusion tractography and arterial spin labelling, and to correlate this with clinical descriptions of the syndrome.

All children referred to Great Ormond Street Hospital for Children with a posterior fossa brain tumour will be imaged pre-operatively, post-operatively and at delayed follow-up. In tandem with this, clinical assessments will be made of children post-operatively to ascertain which patients develop pCMS. In addition, anonymised advanced MRI data on healthy controls will be used as a comparator group.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age <18 Referred and operated upon within study period Brain tumour of cerebellum, IVth ventricle, brainstem undergoing craniotomy for resection (including re-do surgery) No restrictions as to tumour histology or grade (embryonal tumour / glioma / ependymoma) Informed consent given by parents

Exclusion criteria

Non-neoplastic infratentorial lesions Claustrophobia Contraindication to MRI Pregnant female Scans missing at >2 timepoints Tumour resection surgery at another hospital if no pre- or post-operative scans available

Treatment and study plan

Advanced MRI sequences

Diagnostic Test

Structural, diffusion and perfusion MRI sequences

Primary outcomes

  1. Diffusion MRI tractography

    Time frame: 1 year

    To compare diffusion MRI derived tractography of the fronto-cerebellar circuitry (and associated metrics of fractional anisotropy and mean diffusivity) between patients with and without pCMS.

  2. Arterial Spin Labeling Perfusion MRI

    Time frame: 1 year

    To compare cerebral blood flow (a metric derived from perfusion MRI) in frontal lobe regions between patients with and without pCMS.

Secondary outcomes

  1. Clinical measure of severity of pCMS

    Time frame: 1 year

    CMS Severity Score (Robertson 2006 JNS Peds 105: 444-451):

    Clinical diagnosis of pCMS Yes / No

    If yes:

    Time of onset

    • immediately post op
    • Days 1-2
    • Days 2-4
    • => Day 4

    Mutism

    • Mild (<1wk)
    • Moderate (1-4wks)
    • Severe (>4wks)

    Ataxia

    • Mild (<1wk)
    • Moderate (1-4wks)
    • Severe (>4wks)

    Hypotonia

    • Mild (can sit or stand by <1wk)
    • Moderate (can sit or stand by 1-4wks)
    • Severe (can sit or stand by >4wks)

    Irritability

    • Mild (<1wk)
    • Moderate (1-4wks)
    • Severe (>4wks)

    Severe = at least 2 severe features Moderate = at least 2 moderate features or 1 moderate and 1 severe Mild = anything less than above

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Registry information

Official study title

Advanced MRI in Surgery for Posterior Fossa Tumours - Predicting Post-operative Paediatric Cerebellar Mutism Syndrome and Surgical Guidance to Avoid it

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 20, 2018
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.