GlioblastomaPhase 1FLAGNCT02880410
Feasibility Study on LITT for Newly Diagnosed Glioblastoma
A Phase 1 study testing NeuroBlate System and Radiation therapy and temozolomide in people with Glioblastoma, run by Monteris Medical at 4 sites in United States.
Trial summary
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- NeuroBlate System and Radiation therapy and temozolomide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Aug 2017to 14 Sep 2018
- 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
Relevant Inclusion Criteria:
- Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy
- Single enhancing lesion that is >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)
- The patient must be ≥18 years of age
- KPS > 70
- Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.
- Stable cardiovascular, pulmonary health status
Relevant Exclusion Criteria:
- Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
- Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant
- Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
- Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
- Pregnancy, or planning to become pregnant
- Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects
- Patients with multiple or multifocal GBM
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
MD Anderson Cancer Center
Houston, Texas, 77030
Washington University
St Louis, Missouri, 63110
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).
- Conditions
- Glioblastoma
- Being tested
- NeuroBlate System, Radiation therapy and temozolomide
- Keywords
- Glioblastoma, NeuroBlate, LITT, Quality of Life
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroBlate SystemDevice
Laser Interstitial Thermal Therapy
Radiation therapy and temozolomideDrug
Radiation therapy and temozolomide
| Study group | Role | What they receive |
|---|---|---|
| LITT Treatment w/radiation therapy and temozolomide | Experimental | This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide Receives: Device: NeuroBlate System; Drug: Radiation therapy and temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
Measured: 2 Years
Secondary outcomes (3)
Progression-Free Survival Rate
To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System
Measured: 2 Years
Overall Survival
To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System
Measured: 2 Years
Changes in Quality of Life
Characterize the changes in quality of life in subjects with newly diagnosed glioblastoma who are undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start15 Aug 2017
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Why it stopped: Terminated (failure to enroll)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monteris Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manmeet Ahluwalia, MD, Principal investigator, The Cleveland ClinicSujit Prabhu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880410
- Sponsor's protocol ID
- FLAG
- Acronym
- FLAG
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2016
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT02880410
- Acronym / sponsor ID
- FLAG / FLAG
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, NeuroBlate, LITT, Quality of Life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated (failure to enroll)
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Monteris MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 26 Aug 2016 (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.
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LITT Treatment w/radiation therapy and temozolomide | Experimental | Device: NeuroBlate System, Drug: Radiation therapy and temozolomideThis is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 SystemLaser Interstitial Thermal Therapy | Device | LITT Treatment w/radiation therapy and temozolomide |
| Radiation therapy and temozolomideRadiation therapy and temozolomide | Drug | LITT Treatment w/radiation therapy and temozolomide |
Primary outcome
Adverse Events
Time frame: 2 Years
Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
3 secondary outcomes
Progression-Free Survival Rate
Time frame: 2 Years
Overall Survival
Time frame: 2 Years
Changes in Quality of Life
Time frame: 2 Years
Results and safety
The study was stopped early (reason given: Terminated (failure to enroll)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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.
Manmeet Ahluwalia, MD principal investigator
The Cleveland Clinic
Sujit Prabhu, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NeuroBlate System and Radiation therapy and temozolomide in people with Glioblastoma, run by Monteris Medical at 4 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?
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: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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 was stopped early (reason given: Terminated (failure to enroll)). Results are not available in the source record.
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?
Adverse Events (time frame: 2 Years). 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 12 Apr 2024.