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

Tracking Information

First Received Date ^ICMJE

October 23, 2006

Last Updated Date

January 22, 2008

Start Date ^ICMJE

October 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

12 month morbidity and mortality

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00392119 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mid and long term post-intervention complications,
Contra indication for the technique,
Optimize clinical and logistic intervention protocols,
Mean procedure duration
Mean procedure cost

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed 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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Brain Neoplasms
Brain Tumor
Brain Cancer
Recurrent Brain Tumor

Intervention ^ICMJE

Device: MR-guided Laser Interstitial Thermal Therapy System

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients 18 years of age or older
Patients with brain metastasis located in the brain hemispheres
Patient with a brain metastasis smaller or equal to 4 cm in diameter
Patient with primary brain tumor smaller or equal to 4 cm in diameter
Patient previously treated with other therapeutic techniques ( radio-therapy, chemotherapy, immunotherapy) which have failed.

Exclusion Criteria:

Patients less than 18 years old,
Patients presenting contra indication for MRI studies
Patient for which the primary cancer is melanoma or kidney tumors
Patients having a mean life duration longer than 3 months (due to the primary cancer)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ashok Gowda, Ph.D.	713.741.0111	ashok@biotexmedical.com
Contact: Roger J. McNichols, Ph.D.	713.741.0111	roger@biotexmedical.com

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00392119

Responsible Party

Study ID Numbers ^ICMJE

NEUROLITT

Study Sponsor ^ICMJE

BioTex, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Alexandre Carpentier, M.D./ Ph.D.	Hospital Lariboisiere, Paris, France
Study Chair:	Eric Vicaut, Ph.D.	Hospital Lariboisiere, Paris, France
Study Director:	Daniel Reizine, M.D.	Hospital Lariboisiere, Paris, France

Information Provided By

BioTex, Inc.

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP