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Feasibility Study on LITT for Newly Diagnosed Glioblastoma (FLAG)

Primary Purpose

Glioblastoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NeuroBlate System

Radiation therapy and temozolomide

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, NeuroBlate, LITT, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University
Wake Forest Baptist Health
Cleveland Clinic Foundation
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LITT Treatment w/radiation therapy and temozolomide

Arm Description

This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-Free Survival Rate

To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System

Overall Survival

To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System

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

Full Information

NCT ID

NCT02880410

First Posted

August 18, 2016

Last Updated

August 23, 2021

Sponsor

Monteris Medical

1. Study Identification

Unique Protocol Identification Number

NCT02880410

Brief Title

Feasibility Study on LITT for Newly Diagnosed Glioblastoma

Acronym

FLAG

Official Title

Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Terminated

Why Stopped

Terminated (failure to enroll)

Study Start Date

August 15, 2017 (Actual)

Primary Completion Date

September 14, 2018 (Actual)

Study Completion Date

September 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Monteris Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

Glioblastoma, NeuroBlate, LITT, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LITT Treatment w/radiation therapy and temozolomide

Arm Type

Experimental

Arm Description

This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide

Intervention Type

Device

Intervention Name(s)

NeuroBlate System

Intervention Description

Laser Interstitial Thermal Therapy

Intervention Type

Drug

Intervention Name(s)

Radiation therapy and temozolomide

Intervention Description

Radiation therapy and temozolomide

Primary Outcome Measure Information:

Title

Adverse Events

Description

Time Frame

2 Years

Secondary Outcome Measure Information:

Title

Progression-Free Survival Rate

Description

To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System

Time Frame

2 Years

Title

Overall Survival

Description

To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System

Time Frame

2 Years

Title

Changes in Quality of Life

Description

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

Time Frame

2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manmeet Ahluwalia, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sujit Prabhu, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study on LITT for Newly Diagnosed Glioblastoma

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