Advanced MRI for Posterior Fossa Tumours

NCT ID: NCT03471026

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-09

Study Completion Date

2021-04-07

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebellar Mutism Posterior Fossa Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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pCMS+

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

Advanced MRI sequences

Intervention Type DIAGNOSTIC_TEST

Structural, diffusion and perfusion 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

Advanced MRI sequences

Intervention Type DIAGNOSTIC_TEST

Structural, diffusion and perfusion MRI sequences

Controls

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

Advanced MRI sequences

Intervention Type DIAGNOSTIC_TEST

Structural, diffusion and perfusion MRI sequences

Interventions

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Advanced MRI sequences

Structural, diffusion and perfusion MRI sequences

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Clark, PhD

Role: PRINCIPAL_INVESTIGATOR

University College London Institute of Child Health

Kristian Aquilina, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Great Ormond Street Hospital

Sebastian M Toescu, MBChB (Hons)

Role: PRINCIPAL_INVESTIGATOR

University College London Institute of Child Health

Locations

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Great Ormond Street Hospital for Children

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36137658 (View on PubMed)

Other Identifiers

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17NI17

Identifier Type: -

Identifier Source: org_study_id

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