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

Sponsor:	BioTex, Inc.
Information provided by:	BioTex, Inc.
ClinicalTrials.gov Identifier:	NCT00392119

Purpose

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.

Condition	Intervention	Phase
Brain Neoplasms Brain Tumor Brain Cancer Recurrent Brain Tumor	Device: MR-guided Laser Interstitial Thermal Therapy System	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Further study details as provided by BioTex, Inc.:

Primary Outcome Measures:

12 month morbidity and mortality

Secondary Outcome Measures:

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

Estimated Enrollment:	18
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2008

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392119

Contacts

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

Locations

France
Hospital Lariboisiere	Recruiting
Paris, France, 75475
Contact: Alexandre Carpentier, M.D., Ph.D. + 33 1 49958144 alexandre.carpentier@lrb.aphp.fr
Contact: Véronique Jouis + 33 1 40054976 veronique.jouis@lrb.ap-hop-paris.fr
Principal Investigator: Alexandre Carpentier, M.D., Ph.D.
Sub-Investigator: Eric Vicaut, Ph.D.
Sub-Investigator: Daniel Reizine, M.D.

Sponsors and Collaborators

BioTex, Inc.

Investigators

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

More Information

No publications provided

Study ID Numbers:	NEUROLITT
Study First Received:	October 23, 2006
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00392119 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by BioTex, Inc.:

MR-guided therapy
Laser interstitial thermal therapy
brain metastasis
Magnetic Resonance Thermal imaging (MRTI)

Additional relevant MeSH terms:

Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Nervous System Diseases

Neoplasm Metastasis
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009