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

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392119
• Other study ID #: NEUROLITT
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2006
• Last updated: December 30, 2009
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: BioTex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Brain Tumor
• Neoplasms
• Recurrent Brain Tumor

Intervention

Device:
• MR-guided Laser Interstitial Thermal Therapy System

Locations

Country	Name	City	State
France	Hospital Lariboisiere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
BioTex, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 month morbidity and mortality
Secondary	Mid and long term post-intervention complications,
Secondary	Contra indication for the technique,
Secondary	Optimize clinical and logistic intervention protocols,
Secondary	Mean procedure duration
Secondary	Mean procedure cost