Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
BioTex, Inc. |
---|---|
Information provided by: | BioTex, Inc. |
ClinicalTrials.gov Identifier: | NCT00392119 |
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.
Condition | Intervention | Phase |
---|---|---|
Brain Neoplasms Brain Tumor Brain Cancer Recurrent Brain Tumor |
Device: MR-guided Laser Interstitial Thermal Therapy System |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | April 2008 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ashok Gowda, Ph.D. | 713.741.0111 | ashok@biotexmedical.com |
Contact: Roger J. McNichols, Ph.D. | 713.741.0111 | roger@biotexmedical.com |
France | |
Hospital Lariboisiere | Recruiting |
Paris, France, 75475 | |
Contact: Alexandre Carpentier, M.D., Ph.D. + 33 1 49958144 alexandre.carpentier@lrb.aphp.fr | |
Contact: Véronique Jouis + 33 1 40054976 veronique.jouis@lrb.ap-hop-paris.fr | |
Principal Investigator: Alexandre Carpentier, M.D., Ph.D. | |
Sub-Investigator: Eric Vicaut, Ph.D. | |
Sub-Investigator: Daniel Reizine, M.D. |
Principal Investigator: | Alexandre Carpentier, M.D./ Ph.D. | Hospital Lariboisiere, Paris, France |
Study Chair: | Eric Vicaut, Ph.D. | Hospital Lariboisiere, Paris, France |
Study Director: | Daniel Reizine, M.D. | Hospital Lariboisiere, Paris, France |
Study ID Numbers: | NEUROLITT |
Study First Received: | October 23, 2006 |
Last Updated: | January 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00392119 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
MR-guided therapy Laser interstitial thermal therapy brain metastasis Magnetic Resonance Thermal imaging (MRTI) |
Brain Neoplasms Neoplasm Metastasis Central Nervous System Diseases Central Nervous System Neoplasms |
Brain Diseases Nervous System Neoplasms Recurrence |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Nervous System Diseases |