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MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors

2014-08-27 03:41:53 | BioPortfolio

Summary

The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors.

Description

This new "minimally invasive" technique has been tested so far, with success, on animal brain tumor models and on human liver metastasis.

The main purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for the human brain metastasis and primary brain tumors.

As secondary objectives for this clinical study, the following are to be explored:

- Eventual evaluation of the eventual mid and long term post-intervention complications,

- Evaluate the contra indication for the technique,

- Evaluate and optimize clinical and logistic intervention protocols,

- Evaluate the mean duration for the procedure,

- Evaluate the mean cost for the procedure

The clinical trial will include a statistical sample of 12-18 treatments and will run over a period of 18 months. The inclusion period will be for 6 months and the patients will be followed up during 12 months post intervention.

The clinical trial will be performed at the Lariboisiere University Hospital of Paris and the patients will be coming from all the Assistance Publique de Paris ( APHP ) hospitals

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain Neoplasms

Intervention

MR-guided Laser Interstitial Thermal Therapy System

Location

Hospital Lariboisiere
Paris
France
75475

Status

Completed

Source

BioTex, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:53-0400

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