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OpenTrials
Completed

NCT Number: NCT02732769

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GammaKnifePerfexion®

Device

neurosurgery

GammaKnifeIcon®

Device

neurosurgery

Efficast®

Device

Thermoformed mask

MRI

Device

Primary outcomes

  1. Evaluation of pain during the hospitalization (3 days)

    Time frame: 12 months

    Questionary (numeric pain intensity scale)

Secondary outcomes

  1. Evaluation of tumor control at 3 months

    Time frame: 12 months

    No increase of volume greater than 50% on the MRI

  2. Evaluation of tumor control at 6 months

    Time frame: 12 months

    No increase of volume greater than 50% on the MRI

  3. Occurrence of clinical side effects

    Time frame: 12 months

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: Mask

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 11, 2016
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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