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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.
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:
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-guided Laser Interstitial Thermal Therapy System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 12 month morbidity and mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Mid and long term post-intervention complications, | ||
| Contra indication for the technique, | ||
| Optimize clinical and logistic intervention protocols, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Carpentier, M.D./ Ph.D. | Hospital Lariboisiere, Paris, France | Principal Investigator |
| Eric Vicaut, Ph.D. | Hospital Lariboisiere, Paris, France | Study Chair |
| Daniel Reizine, M.D. | Hospital Lariboisiere, Paris, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Lariboisiere | Paris | 75475 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22109661 | Derived | 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. |
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| Mean procedure duration |
| Mean procedure cost |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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