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

Phase 1

Completed

• Conditions: Brain Neoplasms; Brain Tumor; Brain Cancer; Recurrent Brain Tumor

• Registration Number: NCT00392119
• Lead Sponsor: BioTex, Inc.

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-23
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-25
• Study Completion: 2008-12
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-30
• Last Update Posted: 2010-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
12 month morbidity and mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Lariboisiere; 🇫🇷 Paris, France