- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732769
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask. (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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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)
|
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®
|
neurosurgery
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
Investigators
- Study Director: DESALBRES, Assistance Publique Hopitaux de Marseille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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