Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.

Study Overview
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Brief Summary
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the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years. This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.

Official Title
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Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.

Conditions
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Lung Cancer, Brain Metastases

Intervention / Treatment
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* Device: GammaKnifePerfexion®
* Device: GammaKnifeIcon®
* Device: Efficast®
* Device: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery Subject requiring a radiosurgical treatment with LGK Exclusion Criteria: Subject having hurts of the brainstem or para-optics Pregnant women or in feeding period Subject having received previously a whole brain radiotherapy

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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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group treated by radiosurgery with stereotaxic frame<br>Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP) | Device: GammaKnifePerfexion®<br>* neurosurgery<br>Device: MRI<br> <br> |
| Experimental: Group treated by radiosurgery with the thermoformed mask<br>Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast® | Device: GammaKnifeIcon®<br>* neurosurgery<br>Device: Efficast®<br>* Thermoformed mask<br>Device: MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain during the hospitalization (3 days) | Questionary (numeric pain intensity scale) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tumor control at 3 months | No increase of volume greater than 50% on the MRI | 12 months | 
| Evaluation of tumor control at 6 months | No increase of volume greater than 50% on the MRI | 12 months | 
| Occurrence of clinical side effects | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |