A model-based risk-minimizing proton treatment planning concept for brain injury prevention in low-grade glioma patients.
H Sallem, S Harrabi, E Traneus...
https://pubmed.ncbi.nlm.nih.gov/39393467Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05964569
Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma
Led by University Hospital Heidelberg · Updated on 2024-01-05
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Low-grade glioma (LGG) are typically slow-growing brain tumors classified as WHO grade I or II, commonly affecting young adults around their forties. This trial investigates the feasibility of using individualized, model-guided optimization of proton beam treatment planning to reduce late brain lesions and long-term side effects. The study focuses on improving radiotherapy timing and planning to avoid complications like neurocognitive impairment and secondary tumors while maintaining disease control. Participants receive proton beam radiotherapy with either a standard treatment plan or an optimized plan guided by a model calculating normal tissue complication probability (NTCP). The optimization uses advanced software to minimize risks of late contrast-enhancing brain lesions (CEBL) by adjusting dose distributions based on predicted biological effects. The study involves two randomized groups: one with standard treatment plans and one with model-optimized plans, with no further changes after plan approval. Throughout the 24 months following treatment, participants undergo quarterly MRI scans to monitor for brain lesions and tumor progression. Researchers also assess radiation-induced brain injuries, survival outcomes, patient-reported experiences, and quality of life using specific questionnaires. This comprehensive follow-up is designed to evaluate the benefits and safety of model-guided treatment planning in improving long-term outcomes for patients with low-grade glioma.
CONDITIONS
Brief Title
Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Histologically confirmed low-grade glioma
- Indication for definitive or adjuvant radiotherapy
- Ability to understand the nature and personal consequences of the clinical trial
- Written informed consent provided
You will not qualify if you...
- Previous brain irradiation
- Contraindication for contrast-enhanced MRI
- Diagnosis of neurofibromatosis
- Participation in another clinical trial with competing objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of proton beam therapy treatment as planned
Participants receive proton beam therapy with either a standard treatment plan or a model-guided optimized treatment plan to minimize risk of brain lesions.
Treatment visits as scheduled per protocol
Follow-up
Duration - Up to 24 months after completion of treatment
Participants are monitored for up to 24 months after treatment to assess brain lesions, radiation-induced injuries, survival, and quality of life through quarterly MRI scans and patient-reported outcomes.
Quarterly visits for MRI and assessments for up to 24 months
Trial Site Locations
Total: 1 location
1
Department of Radiotherapy, University of Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
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Research Team
S
Semi Harrabi, MD
A
Adriane Lentz-Hommertgen, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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