Feasibility Study on LITT for Newly Diagnosed Glioblastoma (FLAG)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02880410 |
Recruitment Status :
Terminated
(Terminated (failure to enroll))
First Posted : August 26, 2016
Last Update Posted : August 14, 2019
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Condition or disease | Intervention/treatment | Phase |
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Glioblastoma | Device: NeuroBlate System Drug: Radiation therapy and temozolomide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma |
Actual Study Start Date : | August 15, 2017 |
Actual Primary Completion Date : | September 14, 2018 |
Actual Study Completion Date : | September 14, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: LITT Treatment w/radiation therapy and temozolomide
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide
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Device: NeuroBlate System
Laser Interstitial Thermal Therapy Drug: Radiation therapy and temozolomide Radiation therapy and temozolomide |
- 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.
- Progression-Free Survival Rate [ Time Frame: 2 Years ]To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System
- Overall Survival [ Time Frame: 2 Years ]To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System
- Changes in Quality of Life [ Time Frame: 2 Years ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880410
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
Wake Forest Baptist Health | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Manmeet Ahluwalia, MD | The Cleveland Clinic | |
Principal Investigator: | Sujit Prabhu, MD | M.D. Anderson Cancer Center |
Responsible Party: | Monteris Medical |
ClinicalTrials.gov Identifier: | NCT02880410 |
Other Study ID Numbers: |
FLAG |
First Posted: | August 26, 2016 Key Record Dates |
Last Update Posted: | August 14, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Glioblastoma NeuroBlate LITT Quality of Life |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |