Advanced MRI for Posterior Fossa Tumours

Cerebellar Mutism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471026
• Other study ID #: 17NI17
• Status: Completed
• Start date: April 9, 2018
• Est. completion date: April 7, 2021

Study information

• Verified date: December 2020
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 7, 2021
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebellar Mutism
• Infratentorial Neoplasms
• Mutism
• Posterior Fossa Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Advanced MRI sequences
Structural, diffusion and perfusion MRI sequences

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children	London

Sponsors (1)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion MRI tractography	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.	1 year
Primary	Arterial Spin Labeling Perfusion MRI	To compare cerebral blood flow (a metric derived from perfusion MRI) in frontal lobe regions between patients with and without pCMS.	1 year
Secondary	Clinical measure of severity of pCMS	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	1 year