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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00392119 |
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Date of registration:
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23/10/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors
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Scientific title:
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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 |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00392119 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Daniel Reizine, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Lariboisiere, Paris, France |
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Name:
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Eric Vicaut, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Lariboisiere, Paris, France |
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Name:
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Alexandre Carpentier, M.D./ Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Lariboisiere, Paris, France |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain Neoplasms
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Brain Tumor
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Brain Cancer
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Recurrent Brain Tumor
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Intervention(s)
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Device: MR-guided Laser Interstitial Thermal Therapy System
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Primary Outcome(s)
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12 month morbidity and mortality
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Secondary Outcome(s)
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Optimize clinical and logistic intervention protocols,
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Contra indication for the technique,
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Mean procedure duration
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Mean procedure cost
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Mid and long term post-intervention complications,
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Secondary ID(s)
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NEUROLITT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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