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
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2008 |
Est. primary completion date | |
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) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hospital Lariboisiere | Paris |
Lead Sponsor | Collaborator |
---|---|
BioTex, Inc. |
France,
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 |
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