Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Study Overview
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Brief Summary
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This study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. This means that the to be irradiated volume will be modified according to the shape changes of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.

Official Title
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Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Conditions
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Brain Tumor

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary brain tumor (WHO IV, GBM); treated with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy. Brain metastasis (from a solid extracranial tumor) eligible for treatment with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy. Also, postoperative patients with a macroscopic residual tumor lesion can be included (the diagnosis of residual diseases is defined by the treating neurosurgeon or on the MRI executed within 24 hours after the surgery, the diagnosis of residual macroscopic disease should always be confirmed during the neuro-oncology multidisciplinary meeting). Exclusion Criteria: Patients receiving Whole Brain RT (WBRT) Patient with a poor kidney function (GFR < 30 mL/min; CKD 4 and 5; patients on dialysis and patients with acute kidney insufficiency) None, doubtful or very small (<5 mm in its largest dimension) contrast enhancing lesion Patients with a contraindication for MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient brain tumor treated with fractionated radiotherapy<br> | Radiation: Radiotherapy<br>* standard radiotherapy treatment with 1-3 extra MRIs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI parameters in the target volume | functional MRI parameters (permeability, perfusion and diffusion) in the target volume before and during fractional radiotherapy treatment | through study completion, an average of 3 years | 
| anatomical variations in position, shape and size in the target volume | The difference is position shape and size in the target volume before and during fractional radiotherapy treatment. In case there is no macroscopic extension beyond the clinical target volume the new target volumes (gross target volume (GTV) and clinical target volume (CTV).) will also (but later) be delineated for analysis of volume changes, center of mass changes and distance measurements between the delineation on planning MRI versus repeated MRI. | through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between MRI parameters to the treatment outcome | to make a sample size calculation for a future study of imaging marker discovery. | through study completion, an average of 3 years | 
| the correlation between anatomical variations and the treatment outcome | to make a sample size calculation for a future study of imaging marker discovery. | through study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Radiotherapy