Brain NeoplasmsPhase 1NCT00392119
MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors
A Phase 1 study testing MR-guided Laser Interstitial Thermal Therapy System in people with Brain Neoplasms and Brain Tumor, run by BioTex, Inc. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Brain Tumor, Brain Cancer
- What is being tested?
- MR-guided Laser Interstitial Thermal Therapy System
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the detailed description
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:
- Eventual evaluation of the eventual mid and long term post-intervention complications,
- Evaluate the contra indication for the technique,
- Evaluate and optimize clinical and logistic intervention protocols,
- Evaluate the mean duration for the procedure,
- Evaluate the mean cost for the procedure
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
- Conditions
- Brain Neoplasms, Brain Tumor, Brain Cancer, Recurrent Brain Tumor
- Being tested
- MR-guided Laser Interstitial Thermal Therapy System
- Keywords
- MR-guided therapy, Laser interstitial thermal therapy, brain metastasis, Magnetic Resonance Thermal imaging (MRTI)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided Laser Interstitial Thermal Therapy SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startOct 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioTex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandre Carpentier, M.D./ Ph.D., Principal investigator, Hospital Lariboisiere, Paris, FranceEric Vicaut, Ph.D., Study chair, Hospital Lariboisiere, Paris, FranceDaniel Reizine, M.D., Study director, Hospital Lariboisiere, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392119
- Sponsor's protocol ID
- NEUROLITT
- Status last verified
- Dec 2009
- First submitted
- 23 Oct 2006
- Last updated
- 1 Jan 2010
- Results posted
- No
Publications
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.
PubMed 22109661
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00392119
- Acronym / sponsor ID
- NEUROLITT
- Conditions
- Brain Neoplasms, Brain Tumor, Brain Cancer, Recurrent Brain Tumor
- Keywords
- MR-guided therapy, Laser interstitial thermal therapy, brain metastasis, Magnetic Resonance Thermal imaging (MRTI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- BioTex, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Eventual evaluation of the eventual mid and long term post-intervention complications,
- Evaluate the contra indication for the technique,
- Evaluate and optimize clinical and logistic intervention protocols,
- Evaluate the mean duration for the procedure,
- Evaluate the mean cost for the procedure
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-guided Laser Interstitial Thermal Therapy System | Device | – |
Primary outcome
12 month morbidity and mortality
5 secondary outcomes
Mid and long term post-intervention complications,
Contra indication for the technique,
Optimize clinical and logistic intervention protocols,
Mean procedure duration
Mean procedure cost
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2010.
- Derived from this study: PubMed 22109661Carpentier 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Carpentier, M.D./ Ph.D. principal investigator
Hospital Lariboisiere, Paris, France
Eric Vicaut, Ph.D. study chair
Hospital Lariboisiere, Paris, France
Daniel Reizine, M.D. study director
Hospital Lariboisiere, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MR-guided Laser Interstitial Thermal Therapy System in people with Brain Neoplasms and Brain Tumor, run by BioTex, Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 month morbidity and mortality. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00392119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2010; AzTrials last refreshed its copy on 6 Nov 2026.