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

October 1, 2018 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hôpitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: DESALBRES, Assistance Publique Hôpitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

July 27, 2017

Study Completion (Actual)

March 21, 2018

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-40
  • 2015-A01673-46 (Registry Identifier: Ansm)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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