Clinical trial NCT00392119: MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Neoplasms
Brain Tumor
Brain Cancer
Recurrent Brain Tumor
Keywords: MR-guided therapy
Laser interstitial thermal therapy
brain metastasis
Magnetic Resonance Thermal imaging (MRTI)
Lead sponsor: BioTex, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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)

Primary outcomes:
measure: 12 month morbidity and mortality
Secondary outcomes:
measure: Mid and long term post-intervention complications,
measure: Contra indication for the technique,
measure: Optimize clinical and logistic intervention protocols,
measure: Mean procedure duration
measure: Mean procedure cost
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Lariboisiere
Study officials:
affiliation: Hospital Lariboisiere, Paris, France
name: Alexandre Carpentier, M.D./ Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Lariboisiere, Paris, France
name: Eric Vicaut, Ph.D.
role: STUDY_CHAIR
affiliation: Hospital Lariboisiere, Paris, France
name: Daniel Reizine, M.D.
role: STUDY_DIRECTOR
References:
citation: Carpentier A, McNichols RJ, Stafford RJ, Guichard JP, Reizine D, Delaloge S, Vicaut E, Payen D, Gowda A, George B. Laser thermal therapy: real-time MRI-guided and computer-controlled procedures for metastatic brain tumors. Lasers Surg Med. 2011 Dec;43(10):943-50. doi: 10.1002/lsm.21138. Epub 2011 Nov 22.