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

Lung Cancer Clinical Trial

— Mask  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732769
• Other study ID #: 2015-40
• Secondary ID: 2015-A01673-46
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 21, 2018

Study information

• Verified date: April 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 21, 2018
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Lung Cancer
• Neoplasm Metastasis

Intervention

Device:
• GammaKnifePerfexion®
neurosurgery
• GammaKnifeIcon®
neurosurgery
• Efficast®
Thermoformed mask
• MRI

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain during the hospitalization (3 days)	Questionary (numeric pain intensity scale)	12 months
Secondary	Evaluation of tumor control at 3 months	No increase of volume greater than 50% on the MRI	12 months
Secondary	Evaluation of tumor control at 6 months	No increase of volume greater than 50% on the MRI	12 months
Secondary	Occurrence of clinical side effects	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	12 months