FLAG: Feasibility Study on LITT for Newly Diagnosed Glioblastoma

Sponsor

Monteris Medical (Industry)

Overall Status

Terminated

CT.gov ID

NCT02880410

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

0.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Device: NeuroBlate System Drug: Radiation therapy and temozolomide	Phase 1

Study Design

Study Type:

Interventional

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 :

Aug 15, 2017

Actual Primary Completion Date :

Sep 14, 2018

Actual Study Completion Date :

Sep 14, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adverse Events [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.

Secondary Outcome Measures

Progression-Free Survival Rate [2 Years]
To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System
Overall Survival [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University	Saint Louis	Missouri	United States	63110
2	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
3	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
4	MD Anderson Cancer Center	Houston	Texas	United States	77030