Actively Recruiting
Neurocognitive Function After Proton Therapy in Children and Adolescents
Led by Technische Universität Dresden · Updated on 2025-02-06
90
Participants Needed
3
Research Sites
434 weeks
Total Duration
On this page
Sponsors
T
Technische Universität Dresden
Lead Sponsor
G
Gert und Susanna Mayer Stiftung
Collaborating Sponsor
AI-Summary
What this Trial Is About
Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted/analysed/evalutated. In a second step, these results are to be compared with 1. a group of children and adolescents who had only /exclusively had operative therapy and 2. with a healthy control group. Thus, the extent to which these treatment options differ in terms of their short and medium-term effect is assessed. Methods of neurocognitive/neurophysiology brain research approaches are applied that may potentially visualize even small / subtle changes in mental activities/neurocognitive function. Therefore the effects of treatment can be evaluated and the neuropsychological outcome of children and adolescents with brain tumors can be improved.
CONDITIONS
Official Title
Neurocognitive Function After Proton Therapy in Children and Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 8 to 18 years
- Patients with primary brain tumor
- No prior radiotherapy of the brain
- Able to perform repeated neuropsychological tests lasting about 1 hour
- Corrected vision not impaired below 80% or no subjective vision problems
- Corrected hearing not impaired or no subjective hearing problems
- Able to attend follow-up examinations
- Written consent from patient, parent, or guardian
- Brain tumor patients with curative or long-term palliative therapy intent
- Life expectancy greater than 3 years
- For irradiation group: planned proton therapy with local radiation dose over 40 Gy (RBE)
You will not qualify if you...
- Patients younger than 8 or older than 18 years
- Brain metastases from tumors outside the brain
- Receiving intrathecal chemotherapy
- Purely palliative treatment plan
- Unable to perform repeated neuropsychological tests
- Chronic diseases affecting neurological or neuropsychological test results
- Unable to attend follow-up examinations
- No written consent from patient, parent, or guardian
- Participation in another intervention study that conflicts with this study
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy
Dresden, Saxony, Germany, 01307
Actively Recruiting
2
University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics
Dresden, Saxony, Germany, 01307
Actively Recruiting
3
University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology
Dresden, Saxony, Germany, 01307
Actively Recruiting
Research Team
M
Mechthild Krause, Prof. Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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