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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00392119

Enrollment

Registered

2006-10-25

Start date

2006-10-31

Completion date

2008-12-31

Last updated

2010-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer, Brain Neoplasms, Brain Tumor, Recurrent Brain Tumor

Keywords

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

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

Interventions

DEVICEMR-guided Laser Interstitial Thermal Therapy System

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
12 month morbidity and mortality	—

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026