Metastatic Brain TumorLAANTERNNCT02392078

Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System

An observational study of Metastatic Brain Tumor and Primary Brain Tumor, run by Monteris Medical at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Metastatic Brain Tumor, Primary Brain Tumor, Epileptic/Seizure Foci
What is being tested?: NeuroBlate System
Type of treatment: Medical device
How many people: 1,153 participants
Where: 26 sitesUnited States
Study dates: Oct 2015to 30 Sep 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Subjects who present with a brain lesion, epileptic/seizure foci, or movement disorder who have been deemed appropriate candidates, in the opinion of the treating physician, for laser ablation using the NeuroBlate® System.

Who may be able to join

Subject or legally authorized representative provides written authorization and/or consent
Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder

Who cannot join

Subject who is, or is expected to be inaccessible for follow-up
Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator, may prevent participation or otherwise render subject ineligibility for the study

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Northwestern University
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Geisinger Medical Center
Danville, Pennsylvania, 17822
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California, San Diego
La Jolla, California, 92093
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Louisville
Louisville, Kentucky, 40208
Norton Cancer Institute
Louisville, Kentucky, 40241
University of Minnesota
Minneapolis, Minnesota, 55455
Saint Thomas West Hospital and Research Institute
Nashville, Tennessee, 37205
Yale University School of Medicine
New Haven, Connecticut, 06510
New York University Langone Medical Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Children's Hospital of Orange County
Orange, California, 92868
Advent Health Orlando
Orlando, Florida, 32804
Barrow Neurological Institute at Dignity Health St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United Children's Hospital St. Paul
Saint Paul, Minnesota, 55102
Washington University
St Louis, Missouri, 63110
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
The Cleveland Clinic Florida
Weston, Florida, 33331
Wake Forest
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry

The NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS has been used in over 2600 procedures conducted at over 70 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 5 years to evaluate safety, QoL, and procedural outcomes including local control failure rate, progression free survival, overall survival, and seizure freedom in up to 3,000 patients and up to 50 sites.

Conditions: Metastatic Brain Tumor, Primary Brain Tumor, Epileptic/Seizure Foci, Movement Disorders
Being tested: NeuroBlate System
Keywords: Procedural Success, Progression, Quality of Life, Seizure Freedom, Progression Free Survival, Overall Survival
Medical subject headings: Brain Neoplasms, Epilepsy, Movement Disorders, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeuroBlate SystemDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety (Reportable Adverse Events)
Safety profile described by the NBS and surgical-related AEs
Measured: up to 5 years or last follow up
Reason for NeuroBlate
To identify the primary reason the NeuroBlate system was chosen for subject
Measured: Index procedure
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)
Collected for all subjects by disease etiology.
Seizure freedom assessed for all subjects with epilepsy at time of last follow-up. The ENGEL surgical outcome scale is composed of four classes of epilepsy (Class I (best), Class II, Class III, Class IV (worst)) categorized by severity. The ILAE outcome scale contains six classes (Class 1 (best), 2, 3, 4, 5, 6 (worst)) categorized by severity.
Measured: up to 5 years or last follow up
Change in Quality of Life
Assessed with following questionnaires:
1. KPS (malignancy subjects only) Scale range 0-100 measuring the ability of patients with cancer to perform ordinary daily activities. Score 0 is dead, 100 is no disease symptoms
2. FACT-Br (malignancy subjects only) Measure general quality of life across 5 scales- physical well-being, social/family well-being, emotional well-being, functional well-being \& other. Higher score, better quality of life. Range 0-200
3. EQ-5D (tumor/epilepsy subjects only) Measure of health consisting of the descriptive system \& the visual analogue scale (VAS). The system assesses subject mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. Higher score, better quality of life. Range 0-100
4. QOLIE-31 (epilepsy subjects only) 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, \& overall quality of life. Higher score, better quality of life. Range 0-100
Measured: up to 5 years or last follow-up
Number of Patients Demonstrating Local Control and Overall Survival
Collected for all subjects by disease etiology.
Local control as measured by time to local tumor recurrence.
Overall survival assessed by Kaplan-Meier method.
Measured: up to 5 years or last follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201530 Sep 2023

First posted18 Mar 2015 (estimated)
Study startOct 2015
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Metastatic Brain TumorStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02392078
Sponsor's protocol ID: LAANTERN
Acronym: LAANTERN
Status last verified: Apr 2025
First submitted: 12 Mar 2015
Last updated: 24 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Leuthardt EC, Chiang V, Hadjipanayis CG, Landazuri P, Placantonakis DG, Abram SR, Sun DA, Smith KA, Mohammadi AM, Chen CC, Williams BJ, Piccioni DE, Hodges TR, Sloan AE, Lega B, Rodriguez A, Lacroix M, Panov F, Razavi HB, Baumgartner J, Abel TJ, Bandt K, Smyth MD, Rao G, Fecci PE, Laxton AW, Tatter SB, Kim AH, Prabhu SS. Laser Interstitial Thermal Therapy for Brain Tumors: A Prospective Multicenter Analysis of Patients From the LAANTERN Study. J Clin Oncol. 2026 Aug 17:JCO2502604. doi: 10.1200/JCO-25-02604. Online ahead of print.
PubMed 42607280
Landazuri P, Shih J, Leuthardt E, Ben-Haim S, Neimat J, Tovar-Spinoza Z, Chiang V, Spencer D, Sun D, Fecci P, Baumgartner J. A prospective multicenter study of laser ablation for drug resistant epilepsy - One year outcomes. Epilepsy Res. 2020 Nov;167:106473. doi: 10.1016/j.eplepsyres.2020.106473. Epub 2020 Sep 22.
PubMed 33045664
Kim AH, Tatter S, Rao G, Prabhu S, Chen C, Fecci P, Chiang V, Smith K, Williams BJ, Mohammadi AM, Judy K, Sloan A, Tovar-Spinoza Z, Baumgartner J, Hadjipanayis C, Leuthardt EC. Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12-Month Outcomes and Quality of Life After Brain Tumor Ablation. Neurosurgery. 2020 Sep 1;87(3):E338-E346. doi: 10.1093/neuros/nyaa071.
PubMed 32315434
Rennert RC, Khan U, Bartek J, Tatter SB, Field M, Toyota B, Fecci PE, Judy K, Mohammadi AM, Landazuri P, Sloan AE, Kim AH, Leuthardt EC, Chen CC. Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. 2020 Apr 1;86(4):538-547. doi: 10.1093/neuros/nyz141.
PubMed 31076762

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN) Prospective Registry
ClinicalTrials.gov ID: NCT02392078
Acronym / sponsor ID: LAANTERN / LAANTERN
Conditions: Metastatic Brain Tumor, Primary Brain Tumor, Epileptic/Seizure Foci, Movement Disorders
Keywords: Procedural Success, Progression, Quality of Life, Seizure Freedom, Progression Free Survival, Overall Survival
Study type: Observational
Recruitment status: Completed
Enrolment: 1,153 participants (actual)
Lead sponsor: Monteris MedicalIndustry (pharma, biotech, devices)
Study start: Oct 2015 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 18 Mar 2015 (estimated)
Results: Posted 24 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects who present with a brain lesion, epileptic/seizure foci, or movement disorder who have been deemed appropriate candidates, in the opinion of the treating physician, for laser ablation using the NeuroBlate® System.

Key inclusion criteria (2 listed)

Subject or legally authorized representative provides written authorization and/or consent
Subject who is to undergo thermal therapy by the NeuroBlate® System for treatment of their neurological disorder

Key exclusion criteria (2 listed)

Subject who is, or is expected to be inaccessible for follow-up
Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator, may prevent participation or otherwise render subject ineligibility for the study

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
NeuroBlate System	Device	–

Primary outcome

Safety (Reportable Adverse Events)
Time frame: up to 5 years or last follow up
Safety profile described by the NBS and surgical-related AEs
Reason for NeuroBlate
Time frame: Index procedure
To identify the primary reason the NeuroBlate system was chosen for subject
Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)
Time frame: up to 5 years or last follow up
Collected for all subjects by disease etiology. Seizure freedom assessed for all subjects with epilepsy at time of last follow-up. The ENGEL surgical outcome scale is composed of four classes of epilepsy (Class I (best), Class II, Class III, Class IV (worst)) categorized by severity. The ILAE outcome scale contains six classes (Class 1 (best), 2, 3, 4, 5, 6 (worst)) categorized by severity.
Change in Quality of Life
Time frame: up to 5 years or last follow-up
Assessed with following questionnaires: 1. KPS (malignancy subjects only) Scale range 0-100 measuring the ability of patients with cancer to perform ordinary daily activities. Score 0 is dead, 100 is no disease symptoms 2. FACT-Br (malignancy subjects only) Measure general quality of life across 5 scales- physical well-being, social/family well-being, emotional well-being, functional well-being \& other. Higher score, better quality of life. Range 0-200 3. EQ-5D (tumor/epilepsy subjects only) Measure of health consisting of the descriptive system \& the visual analogue scale (VAS). The system assesses subject mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. Higher score, better quality of life. Range 0-100 4. QOLIE-31 (epilepsy subjects only) 7 scales assessing emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, \& overall quality of life. Higher score, better quality of life. Range 0-100
Number of Patients Demonstrating Local Control and Overall Survival
Time frame: up to 5 years or last follow up
Collected for all subjects by disease etiology. Local control as measured by time to local tumor recurrence. Overall survival assessed by Kaplan-Meier method.

Results and safety

Results posted to the registry on 24 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metastatic Brain Tumor	374	342
Primary Brain Tumor	488	445
Epileptic/Seizure Foci	288	268
Movement Disorders	3	2

Primary outcome: Safety (Reportable Adverse Events)

Time frame: up to 5 years or last follow up. Count of participants. Unit: Participants

Measure	Number of Participants n = 1057
Anxiety	1
Aphasia	7
Ataxia or loss of body coordination	2
Bleeding or increased risk of bleeding into or around the brain	30
Blurry vision/visual disturbance/Permanent neuro deficit	3
Cerebral edema/Edema	21
Cerebral infarction	1
Complete or incomplete hemiparesis	2

Primary outcome: Reason for NeuroBlate

Time frame: Index procedure. Number. Unit: participants

Measure	Subjects Treated With NeuroBlate LITT n = 1057
Minimally Invasive Preferred	702
Non-Resectable	186
Subject exceeded max dose or could not tolerate radiation	24
Subject not a candidate for craniotomy	31
Palliative	7
Other	139
Unknown	37

Primary outcome: Number of Patients Demonstrating Seizure Freedom (ENGEL and ILAE Classifications)

Time frame: up to 5 years or last follow up. Count of participants. Unit: Participants

Measure	Metastatic Brain Tumor n = 342	Primary Brain Tumor n = 445	Epileptic/Seizure Foci n = 268	Movement Disorders n = 2
ENGEL I	–	–	88	–
ENGEL II	–	–	34	–
ENGEL III	–	–	29	–
ENGEL IV	–	–	21	–
ENGEL Not Provided	–	–	96	–
ILAE 1	–	–	58	–
ILAE 2	–	–	25	–
ILAE 3	–	–	31	–

Population analysed: Data not collected for various cohorts because they were not applicable to the end points associated with those cohorts disease state.

Primary outcome: Change in Quality of Life

Time frame: up to 5 years or last follow-up. Median (Full Range). Unit: score on a scale

Measure	Metastatic Brain Tumor n = 342	Primary Brain Tumor n = 445	Epileptic/Seizure Foci n = 268	Movement Disorders n = 2
KPS	90 (0 to 100)	80 (10 to 100)	–	–
FACT Br	149 (49 to 200)	149 (49 to 200)	–	–
EQ-5D	80 (5 to 100)	80 (5 to 100)	80 (1 to 100)	–
QOLIE-31	–	–	65.3 (7 to 96)	–

Population analysed: The questionnaires are only applicable to certain cohorts in the study population and were not collected or analyzed for subjects who were not in that cohort.

Adverse events

Time frame: Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion which varied for each subject, but up to 5 years. From time of consent to withdraw varied based on death or study withdraw. Adverse events were monitored throughout the subjects study participation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Number of Participants With Adverse Events	31 of 1,057 (2.9%)	169 of 1,057 (16%)	367 of 1,057

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42607280Leuthardt EC, Chiang V, Hadjipanayis CG, Landazuri P, Placantonakis DG, Abram SR, Sun DA, Smith KA, Mohammadi AM, Chen CC, Williams BJ, Piccioni DE, Hodges TR, Sloan AE, Lega B, Rodriguez A, Lacroix M, Panov F, Razavi HB, Baumgartner J, Abel TJ, Bandt K, Smyth MD, Rao G, Fecci PE, Laxton AW, Tatter SB, Kim AH, Prabhu SS. Laser Interstitial Thermal Therapy for Brain Tumors: A Prospective Multicenter Analysis of Patients From the LAANTERN Study. J Clin Oncol. 2026 Aug 17:JCO2502604. doi: 10.1200/JCO-25-02604. Online ahead of print.
Derived from this study: PubMed 33045664Landazuri P, Shih J, Leuthardt E, Ben-Haim S, Neimat J, Tovar-Spinoza Z, Chiang V, Spencer D, Sun D, Fecci P, Baumgartner J. A prospective multicenter study of laser ablation for drug resistant epilepsy - One year outcomes. Epilepsy Res. 2020 Nov;167:106473. doi: 10.1016/j.eplepsyres.2020.106473. Epub 2020 Sep 22.
Derived from this study: PubMed 32315434Kim AH, Tatter S, Rao G, Prabhu S, Chen C, Fecci P, Chiang V, Smith K, Williams BJ, Mohammadi AM, Judy K, Sloan A, Tovar-Spinoza Z, Baumgartner J, Hadjipanayis C, Leuthardt EC. Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12-Month Outcomes and Quality of Life After Brain Tumor Ablation. Neurosurgery. 2020 Sep 1;87(3):E338-E346. doi: 10.1093/neuros/nyaa071.
Derived from this study: PubMed 31076762Rennert RC, Khan U, Bartek J, Tatter SB, Field M, Toyota B, Fecci PE, Judy K, Mohammadi AM, Landazuri P, Sloan AE, Kim AH, Leuthardt EC, Chen CC. Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. 2020 Apr 1;86(4):538-547. doi: 10.1093/neuros/nyz141.

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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.

Eric Leuthardt, MD principal investigator

Washington University School of Medicine

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Brain Tumor and Primary Brain Tumor, run by Monteris Medical at 26 sites 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 2 inclusion and 2 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety (Reportable Adverse Events) (time frame: up to 5 years or last follow up). The study lists 5 primary outcomes in all. 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 NCT02392078, which also lists 4 linked publications.

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 24 Apr 2025.