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

Recruiting

Conditions: Neuropsychological deficits
pediatric brain tumor
10029211

Registration Number: NL-OMON51677

Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

- 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Age-standardized performance on other neuropsychological measures (estimated<br /><br>IQ, working memory, processing speed, executive functioning, memory,<br /><br>visual-motor, questionnaires), clinical data (demographic, treatment, RT dose,<br /><br>complications), and premorbid history (birth, health, school, SES). </p><br>