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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Brain Metastases; Lung Cancer

Treatments: Device: GammaKnifePerfexion®; Device: Efficast®; Device: MRI; Device: GammaKnifeIcon®

Study type: Interventional

Funder types: Other

Identifiers

NCT02732769

2015-A01673-46 (Registry Identifier)

2015-40

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Group treated by radiosurgery with stereotaxic frame

Active Comparator group

Description:

Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)

Treatment:

Device: MRI

Device: GammaKnifePerfexion®

Group treated by radiosurgery with the thermoformed mask

Experimental group

Description:

Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®

Treatment:

Device: MRI

Device: GammaKnifeIcon®

Device: Efficast®