MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors
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
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2006
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 23, 2006
CompletedFirst Posted
Study publicly available on registry
October 25, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 1, 2010
December 1, 2009
October 23, 2006
December 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12 month morbidity and mortality
Secondary Outcomes (5)
Mid and long term post-intervention complications,
Contra indication for the technique,
Optimize clinical and logistic intervention protocols,
Mean procedure duration
Mean procedure cost
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioTex, Inc.lead
Study Sites (1)
Hospital Lariboisiere
Paris, 75475, France
Related Publications (1)
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.
PMID: 22109661DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 23, 2006
First Posted
October 25, 2006
Study Start
October 1, 2006
Study Completion
December 1, 2008
Last Updated
January 1, 2010
Record last verified: 2009-12