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

NCT02732769 | Completed

• 2 other identifiers: 2015-402015-A01673-46
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Evaluation of pain during the hospitalization (3 days)

  Questionary (numeric pain intensity scale)

  12 months

Secondary Outcomes (3)

• Evaluation of tumor control at 3 months

  12 months

• Evaluation of tumor control at 6 months

  12 months

• Occurrence of clinical side effects

  12 months

Study Arms (2)

Group treated by radiosurgery with stereotaxic frame

ACTIVE COMPARATOR

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

Device: GammaKnifePerfexion®; Device: MRI

Group treated by radiosurgery with the thermoformed mask

EXPERIMENTAL

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

Device: GammaKnifeIcon®; Device: Efficast®; Device: MRI

Interventions

GammaKnifePerfexion® DEVICE

neurosurgery

Group treated by radiosurgery with stereotaxic frame

GammaKnifeIcon® DEVICE

neurosurgery

Group treated by radiosurgery with the thermoformed mask

Efficast® DEVICE

Thermoformed mask

Group treated by radiosurgery with the thermoformed mask

MRI DEVICE

Group treated by radiosurgery with stereotaxic frame; Group treated by radiosurgery with the thermoformed mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject having hurts of the brainstem or para-optics
• Pregnant women or in feeding period
• Subject having received previously a whole brain radiotherapy

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• DESALBRES

  ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 11, 2016
• Study Start: February 1, 2016
• Primary Completion: July 27, 2017
• Study Completion: March 21, 2018
• Last Updated: October 3, 2018

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)