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SIMBA study: Imaging study of Cognitive Outcomes after Treatment for Pediatric Brain Tumor

SIMBA study: Seven Tesla Imaging Biomarkers of Cognitive Outcomes after Treatment for Pediatric Brain Tumor - SIMBA study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51677
Enrollment
30
Registered
2021-12-21
Start date
2022-08-23
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropsychological deficits pediatric brain tumor

Interventions

7T MRI, questionnaires, neuropsychological tests

Sponsors

Prinses Máxima Centrum voor Kinderoncologie
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age between 6 and 23 years old  - Have been treated for a posterior fossa brain tumor with surgery/chemotherapy only, focal proton radiotherapy, or cranial-spinal proton radiotherapy  - At least 6 months and up to 5 years after diagnosis, and completed treatment - Able to complete MRI without anaesthesia

Exclusion criteria

Exclusion criteria: - No signed informed consent (either by patient and/or parents/legal guardian) - Insufficient knowledge of the Dutch language to perform the neuropsychological assessment or complete questionnaires - Significant visual, motor, or developmental problems and thus alternative neuropsychological assessments would be needed (e.g., blindness, deafness, profound developmental delay) - MRI-specific exclusion criteria, such as metal implants. Screening for MRI specific exclusion criteria will be done using the typical 7-Tesla MRI safety screening.

Design outcomes

Primary

MeasureTime frame
Age-standardized performance on a sustained attention task (K-CPT-2/CPT-3 measure) is the endpoint of the main analysis. The 7T MRI metrics measuring vasculature, metabolism, and white matter diffusion in the brain will be used to predict performance on this task.

Secondary

MeasureTime frame
Age-standardized performance on other neuropsychological measures (estimated IQ, working memory, processing speed, executive functioning, memory, visual-motor, questionnaires), clinical data (demographic, treatment, RT dose, complications), and premorbid history (birth, health, school, SES).

Countries

Netherlands

Contacts

Public ContactM.H. Partanen

Prinses Máxima Centrum voor Kinderoncologie

m.h.partanen@prinsesmaximacentrum.nl+31 88 972 72 72

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)