Feasibility Study on LITT for Newly Diagnosed Glioblastoma (FLAG)

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).

Study Overview

• Status: Terminated
• Conditions: Glioblastoma
• Intervention / Treatment: Device: NeuroBlate System; Drug: Radiation therapy and temozolomide

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Relevant Inclusion Criteria:

1. Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy
2. Single enhancing lesion that is >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)
3. The patient must be ≥18 years of age
4. KPS > 70
5. 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.
6. Stable cardiovascular, pulmonary health status

Relevant Exclusion Criteria:

1. Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
2. Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant
3. Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
4. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
5. Pregnancy, or planning to become pregnant
6. 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
7. Patients with multiple or multifocal GBM

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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	Device: NeuroBlate System; Laser Interstitial Thermal Therapy; Drug: Radiation therapy and temozolomide; Radiation therapy and temozolomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival Rate	To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System	2 Years
Overall Survival	To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System	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	2 Years

Collaborators and Investigators

• Sponsor: Monteris Medical
• Investigators: Principal Investigator: Sujit Prabhu, MD, M.D. Anderson Cancer Center; Principal Investigator: Manmeet Ahluwalia, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): September 14, 2018

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimated): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Glioblastoma; LITT; NeuroBlate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: FLAG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes