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The Clinical Evaluation of the Stereotactic, MR Guided, Laser Interstitial Thermal Therapy (LITT ) for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors - a Phase I Study With Direct Patient Benefice
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Lariboisiere
Paris, France
Start Date
October 1, 2006
Completion Date
December 1, 2008
Last Updated
January 1, 2010
18
ESTIMATED participants
MR-guided Laser Interstitial Thermal Therapy System
DEVICE
Lead Sponsor
BioTex, Inc.
NCT05839379
NCT06962215
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05588141