Advanced MRI for Posterior Fossa Tumours

NCT03471026 | Completed DMC

• 1 other identifier: 17NI17
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebellar Mutism; Posterior Fossa Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Clinical measure of severity of pCMS

  1 year

Study Arms (3)

pCMS+

Children undergoing infratentorial craniotomy for brain tumour resection whom develop pCMS will undergo pre-, post-operative and delayed follow-up advanced MRI sequences

Diagnostic Test: Advanced MRI sequences

pCMS-

Children undergoing infratentorial craniotomy for brain tumour resection whom do not develop pCMS will undergo pre-, post-operative and delayed follow-up advanced MRI sequences

Diagnostic Test: Advanced MRI sequences

Controls

Healthy control children whom have never undergone intracranial surgery have had advanced MRI sequences acquired

Diagnostic Test: Advanced MRI sequences

Interventions

Advanced MRI sequences DIAGNOSTIC_TEST

Structural, diffusion and perfusion MRI sequences

Controls; pCMS+; pCMS-

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children referred to our institution with a brain tumour of the posterior fossa

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

Location

Related Publications (1)

• Toescu SM, Hales PW, Cooper J, Dyson EW, Mankad K, Clayden JD, Aquilina K, Clark CA. Arterial Spin-Labeling Perfusion Metrics in Pediatric Posterior Fossa Tumor Surgery. AJNR Am J Neuroradiol. 2022 Oct;43(10):1508-1515. doi: 10.3174/ajnr.A7637. Epub 2022 Sep 22.

  PMID: 36137658 DERIVED

Study Officials

• Chris Clark, PhD

  University College London Institute of Child Health

  PRINCIPAL INVESTIGATOR

• Kristian Aquilina, MD, FRCS

  Great Ormond Street Hospital

  PRINCIPAL INVESTIGATOR

• Sebastian M Toescu, MBChB (Hons)

  University College London Institute of Child Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 20, 2018
• Study Start: April 9, 2018
• Primary Completion: September 9, 2020
• Study Completion: April 7, 2021
• Last Updated: July 7, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)