MRI research into changes in the brain and cognitive functioning after treatment for pediatric brain tumor

Not Applicable

• Conditions: Pediatric brain tumor treated with radiation therapy; Cancer

• Registration Number: ISRCTN15453405
• Lead Sponsor: Princess Máxima Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-21
• Last Update Posted: 18 June 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Age between 6 - 23 years old
2. Have been treated for a posterior fossa brain tumor with surgery/chemotherapy only, focal proton RT, or cranial-spinal proton RT
3. At least 6 months and up to 5 years after diagnosis, and completed treatment
4. Able to complete MRI without anesthesia

Exclusion Criteria

1. No signed informed consent (either by patient and/or parents/legal guardian)
2. Insufficient knowledge of the Dutch language to perform the neuropsychological assessment or complete questionnaires
3. Significant visual, motor, or developmental problems and thus alternative neuropsychological assessments would be needed (e.g., blindness, deafness, profound developmental delay)
4. 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. The screening form is attached to this proposal

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured once:<br>1. Performance on a sustained attention task (K-CPT-2/CPT-3 measure)<br>2. 7T MRI metrics measuring vascular health, metabolism, and diffusion in the brain measured using MRI processing