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

Seven tesla imaging biomarkers of cognitive outcome after treatment for pediatric brain tumor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15453405
Enrollment
30
Registered
2022-04-21
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Pediatric brain tumor treated with radiation therapy Cancer

Interventions

For this observational study, participants will complete one 7 Tesla MRI scan. From this scan, parameters of brain vasculature, metabolism and white matter diffusion will be obtained. Additionally, a

Sponsors

Princess Máxima Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 23 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. Neuropsychological measures: 1.1 Estimated IQ measured using the Vocabulary and Matrix Reasoning subtests from WISC-V/WAIS-IV at 1-5 years after diagnosis 1.2 Working memory measured using the Digit Span, Picture Span and/or Arithmetic subtests from WISC-V/WAIS-IV at 1-5 years after diagnosis 1.3. Processing speed measured using the Coding and Symbol Search subtests from WISC-V/WAIS-IV at 1-5 years after diagnosis 1.4. Executive functioning measured using the subtests Road Walking and Word Naming from IDS-2 at 1-5 years after diagnosis 1.5. Memory measured using RAVLT at 1-5 years after diagnosis 1.6. Visual-motor measured using the Purdue Pegboard at 1-5 years after diagnosis 1.7. Questionnaires filled out by parents and/or patients to measure executive skills (BRIEF-2/BRIEF-A), behavior (SDQ parent/SDQ informant), quality of life (PedsQL Generic), fatigue (PedsQL Fatigue) and pre-morbid medical, psychosocial and school functioning (PAT2.0). All neuropsychological measures are administered at one timepoint at 1-5 years after diagnosis. Parents are asked to complete the questionnaires via a safe, online KLIK portal at this same timepoint 2. Clinical, biological, and psychosocial variables will be identified from the medical record and parent questionnaires. This will include clinical data (e.g., demographic, treatment, RT dose, complications), and premorbid history (e.g., birth, health, school, SES). Scores are either continuous or categorical (yes/no) depending on the metric.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026