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
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
12 month morbidity and mortality
Alexandre Carpentier, M.D./ Ph.D.
Hospital Lariboisiere, Paris, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)