Brain NeoplasmsPhase 1/2NCT00787982
Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
A Phase 1/2 study testing MRI-Guided Laser Induced Thermal Therapy in people with Brain Neoplasms, run by Visualase, Inc. at 1 site in United States.
Trial summary
In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- MRI-Guided Laser Induced Thermal Therapy
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2010
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient or family able and willing to give informed consent.
- Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).
- Three or fewer previously treated or untreated lesion(s) in the brain.
- Tumor size ≤ 3.0 cm in largest diameter.
- MR imaging is not contraindicated for the patient.
- Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
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- Able and willing to attend all study visits.
- Karnofsky Performance Scale score >70 for patients over the age of 15.
- Lansky Play Scale >70 for patients 15 years of age or younger.
Who cannot join
- Patients or family unwilling or unable to give written consent.
- Patients who cannot physically fit in, or are too heavy for, the MRI scanner.
- Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.
- Known sensitivity to gadolinium-DTPA.
- Based on Treatment Planning Imaging (MR and/or CT):
- Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm.
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- Lesions localized in the brain stem.
- Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
- Evidence of recent (<2 weeks) hemorrhage.
- Presence of more than 3 brain tumors at the time of enrollment.
- Symptoms and signs of increased intracranial pressure.
- Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
- Patients who are unable to receive corticosteroids.
- Positive pregnancy test for women of child-bearing age.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
pamela kribs, R.N.,BSN, 516-562-3058, pkribs@NSHS.edu
Michael Schulder, MD
About this study
Official title: Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.
Read the detailed description
The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) to the tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment.
The Visualase Thermal Therapy System will be used in this study to give subjects a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.
- Conditions
- Brain Neoplasms
- Being tested
- MRI-Guided Laser Induced Thermal Therapy
- Keywords
- brain, metastasis, neoplasm, tumor, Patients with secondary brain neoplasms, laser therapy, laser interstitial thermal therapy
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-Guided Laser Induced Thermal TherapyDevice
LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of technical success or failure to complete the initial procedure with no associated major complications.
Measured: within 24 hours following the procedure
Secondary outcomes (5)
Examination of the extent to which Visualase predictions based on MRTI data match lesion dimensions form post-therapy MRI assessments.
Measured: Immediately following treatment (day 0)
Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure
Measured: from day 0 to patient release
Local control of treated lesions as defined by volume of lesions increasing by no more than 25%
Measured: Day 30, 90, and 180 days post procedure
Accrual of patient survival post Visualase therapy
Measured: Sooner of 3 years or patient death
Procedure-related morbidity and mortality
Measured: 30, 90,180 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Visualase, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787982
- Sponsor's protocol ID
- VIS-BR-08-001
- Status last verified
- Dec 2009
- First submitted
- 29 Oct 2008
- Last updated
- 1 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
- Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT00787982
- Acronym / sponsor ID
- VIS-BR-08-001
- Conditions
- Brain Neoplasms
- Keywords
- brain, metastasis, neoplasm, tumor, Patients with secondary brain neoplasms, laser therapy, laser interstitial thermal therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Visualase, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 10 Nov 2008 (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.
In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.
Detailed description
The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) to the tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment.
The Visualase Thermal Therapy System will be used in this study to give subjects a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient or family able and willing to give informed consent.
- Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).
- Three or fewer previously treated or untreated lesion(s) in the brain.
- Tumor size ≤ 3.0 cm in largest diameter.
- MR imaging is not contraindicated for the patient.
Key exclusion criteria (14 listed)
- Patients or family unwilling or unable to give written consent.
- Patients who cannot physically fit in, or are too heavy for, the MRI scanner.
- Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.
- Known sensitivity to gadolinium-DTPA.
- Based on Treatment Planning Imaging (MR and/or CT):
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 |
|---|---|---|
| MRI-Guided Laser Induced Thermal TherapyLITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor | Device | – |
Primary outcome
Rate of technical success or failure to complete the initial procedure with no associated major complications.
Time frame: within 24 hours following the procedure
5 secondary outcomes
Examination of the extent to which Visualase predictions based on MRTI data match lesion dimensions form post-therapy MRI assessments.
Time frame: Immediately following treatment (day 0)
Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure
Time frame: from day 0 to patient release
Local control of treated lesions as defined by volume of lesions increasing by no more than 25%
Time frame: Day 30, 90, and 180 days post procedure
Accrual of patient survival post Visualase therapy
Time frame: Sooner of 3 years or patient death
Procedure-related morbidity and mortality
Time frame: 30, 90,180 days post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2010.
- Sponsors websiteLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MRI-Guided Laser Induced Thermal Therapy in people with Brain Neoplasms, run by Visualase, Inc. at 1 site in United States.
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 9 inclusion and 14 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: status not confirmed, 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pamela Kribs, R.N., BSN (516-562-3058, pkribs@NSHS.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of technical success or failure to complete the initial procedure with no associated major complications. (time frame: within 24 hours following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.