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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms, Brain Tumor, Brain Cancer, Recurrent Brain Tumor

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

12 month morbidity and mortality

Principal Investigator

Alexandre Carpentier, M.D./ Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Lariboisiere, Paris, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

NEUROLITT

NCT ID:

NCT00392119

Start Date:

October 2006

Completion Date:

December 2008

Related Keywords:

  • Brain Neoplasms
  • Brain Tumor
  • Brain Cancer
  • Recurrent Brain Tumor
  • MR-guided therapy
  • Laser interstitial thermal therapy
  • brain metastasis
  • Magnetic Resonance Thermal imaging (MRTI)
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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