Research into clinical and MRI measures to get understanding of the neuropsychological outcome of children undergoing surgery for a brain tumor
| ISRCTN | ISRCTN70465429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70465429 |
| Secondary identifying numbers | MN21FAS |
- Submission date
- 20/12/2023
- Registration date
- 28/05/2024
- Last edited
- 28/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Central nervous system (CNS) tumours comprise 25% of all childhood cancers, and more than half of these are located in the cerebellum. After an operation for such a tumour, up to 25% of children may experience cerebellar mutism syndrome (CMS). It is characterized by mutism, hypotonia, ataxia and irritability, and the exact causes have yet to be identified. Although a cure may have been achieved for their brain tumour, the CMS and its consequences can still pose a lifelong challenge for these children. Since about half of paediatric brain tumours are located in the posterior fossa and require surgery, CMS is a common and serious issue in paediatric neuro-oncology. The main aim of this study is to investigate early clinical and neuroradiological (MRI) predictors of neuropsychological outcomes in children with posterior fossa tumors. Additionally, the study aims to identify group differences and changes over time in neuroradiological and neuropsychological measures for children with higher versus lower CMS symptom severity.
Who can participate?
Children participating in the European CMS study are also eligible for the FASTigial study. Children (2-18 years old) requiring surgery for a cerebellar (posterior fossa) tumor at one of the participating centers will be included after informed consent has been obtained. Additionally, patients must understand and be able to speak the local language. In contrast to the European CMS study, patients who have undergone surgery previously CANNOT participate in FASTigial.
The targeted number of included patients is 210, with 80 children expected to be included at the Princess Maxima Center for Pediatric Oncology.
What does the study involve?
Patients participating in the study will be treated according to local standards. Additionally, we will perform neuropsychological tests before surgery, directly after surgery, and 12 months after surgery using digital tests lasting about 30 minutes each time. While the child completes the neuropsychological tests, the parent(s) will be asked to complete several questionnaires. Furthermore, the child will undergo an MRI scan as part of standard care. Two additional MRI sequences will be added to the clinical protocol, including diffusion and perfusion scan techniques.
What are the possible benefits and risks of participating?
Participation in the study will not impact or interfere with the child's treatment plan. The child will not experience any extra benefits or risks. The administration of neuropsychological tests carries no risk. The additional MRI sequences are obtained when the patient undergoes a clinical MRI, thus the patient is not at risk.
Patients may even benefit from additional explanations and guidance provided by the researchers. In contrast, the study yields crucial insights into the etiology of cerebellar mutism and the factors influencing its onset and recovery.
Where is the study run from?
The Princess Máxima Center Utrecht (the Netherlands)
When is the study starting and how long is it expected to run for?
From April 2024 to October 2027
Who is funding the study?
Children Cancer Free Foundation (Stichting Kinderen Kankervrij) (the Netherlands)
Who is the main contact?
Marita Partanen, M.H.Partanen@prinsesmaximacentrum.nl
Contact information
Public, Scientific, Principal Investigator
Heidelberglaan 25
Utrecht
3584CS
Netherlands
 ORCID ID |
0000-0003-1018-9778 |
|---|---|
| Phone | +31 889727272 |
| M.H.Partanen@prinsesmaximacentrum.nl |
Study information
| Study design | Multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Prevention, Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | FASTigial: Finding Anatomical SubsTrates of neuropsychological outcome in children with posterior fossa tumors (add-on project on the European CMS study) |
| Study acronym | FASTigial |
| Study objectives | It is expected that clinical criteria, CMS symptom severity, and changes in neuroradiological findings over time will predict neuropsychological outcome at 12 months after surgery. Patients with higher versus lower CMS symptom severity will have greater pre- and post-operative damage to white matter tracts (DTI), leading to changes in perfusion (ASL). Also, those with higher versus lower CMS severity will have significant impairments across neuropsychological domains, particularly in executive functioning, attention, processing speed and emotional-behavioral domains. Some deficits will be shown at the pre-surgery phase, but impairments will become more apparent post-surgery. Some children will show recovery over time, however, those with greater CMS symptoms will have slower recovery. |
| Ethics approval(s) |
Approved 03/04/2024, Medisch-Ethische Toetsingscommissie NedMec (Huispost D01.343 Postbus 85500, Utrecht, 3508 GA, Netherlands; +31 88-7556376; metc@nedmec.nl), ref: NL85971.041.23 |
| Health condition(s) or problem(s) studied | Newly diagnosed pediatric brain tumors located in the posterior fossa |
| Intervention | For this multicenter observational study, patients participating in the study will be treated according to local standards. Additionally, we will conduct neuropsychological tests preoperatively, postoperatively, and 12 months after surgery using digital tests that take approximately 30 minutes each time. While the child completes the neuropsychological tests, the parent(s) will be asked to complete several questionnaires. Furthermore, the child will undergo MRI scans as part of standard care. Two additional MRI sequences will be added to the clinical protocol, including diffusion (DTI) and perfusion (ASL) scan techniques. A neurological scale will be completed. Other medical information will be retrieved from the database of the European CMS study (to which the FASTigial study is an add-on)(www.ClinicalTrials.gov; NCT02300766). |
| Intervention type | Other |
| Primary outcome measure | 1. Age-standardized performance on executive functioning (neuropsychological domain) measured using questionnaires filled in by parents preoperatively, postoperatively, and 12 months after surgery. 2. White matter integrity and perfusion in the brain measured using MRI and clinical data (e.g., age, treatment) will be used to investigate early clinical and neuroradiological predictors of neuropsychological outcome preoperatively, postoperatively, and 12 months after surgery. |
| Secondary outcome measures | 1. Age-standardized performance on neuropsychological measures, measured using computerized tests (Cogstate) and questionnaires preoperatively, postoperatively, and 12 months after surgery. 2. Clinical, neuroradiological (white matter integrity and perfusion) and neuropsychological variables will be collected to identify group differences and changes over time in posterior fossa tumor patients who have higher versus lower CMS symptom severity preoperatively, postoperatively, and 12 months after surgery. |
| Overall study start date | 01/02/2023 |
| Completion date | 01/10/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 210 |
| Key inclusion criteria | Eligible for European CMS study 1. Age 2-18 years at the date of first imaging showing this tumour 2. Understanding and speaking of local language by patient and/or parents Inclusion criteria European CMS study: 1. Age <18 years at the date of first imaging showing this tumour 2. Tumour in the cerebellum/4th ventricle/brainstem with the intention to treat with surgical resection or open biopsy. |
| Key exclusion criteria | 1. Patients who have had previous surgery on the posterior fossa 2. No informed consent from custodial parent(s) and/or patient |
| Date of first enrolment | 01/04/2024 |
| Date of final enrolment | 01/10/2026 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Utrecht
3584 CS
Netherlands
Sponsor information
Hospital/treatment centre
Heidelberglaan 25
Utrecht
3584 CS
Netherlands
| Phone | +31 889727272 |
|---|---|
| info@prinsesmaximacentrum.nl | |
| Website | https://www.prinsesmaximacentrum.nl/en |
"ROR" |
https://ror.org/02aj7yc53 |
Funders
Funder type
Not defined
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Children Cancer Free Foundation, KiKa
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in peer-reviewed journals, scientific presentations at international conferences |
| IPD sharing plan | During the conduct of the study the data is under embargo. After study completion data sharing plans will be made available. |
Editorial Notes
03/05/2024: Trial's existence confirmed by Medisch-Ethische Toetsingscommissie NedMec.
