Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
NCT ID: NCT02732769
Last Updated: 2018-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
58 participants
INTERVENTIONAL
2016-02-29
2018-03-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Immobilisation Shells in Cranial Radiotherapy
NCT02599142
S-Frame CT Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer
NCT00252473
Frameless Stereotactic Radiosurgery for Brain Metastases
NCT01476878
A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases
NCT01543542
Stereotactic Magnetic Resonance Guided Radiation Therapy
NCT04115254
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group treated by radiosurgery with stereotaxic frame
Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
GammaKnifePerfexion®
neurosurgery
MRI
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®
GammaKnifeIcon®
neurosurgery
Efficast®
Thermoformed mask
MRI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GammaKnifePerfexion®
neurosurgery
GammaKnifeIcon®
neurosurgery
Efficast®
Thermoformed mask
MRI
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject requiring a radiosurgical treatment with LGK
Exclusion Criteria
* Pregnant women or in feeding period
* Subject having received previously a whole brain radiotherapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
DESALBRES
Role: STUDY_DIRECTOR
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-A01673-46
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-40
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.