Feasibility Study on LITT for Newly Diagnosed Glioblastoma

Glioblastoma Clinical Trial

— FLAG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02880410
• Other study ID #: FLAG
• Status: Terminated
• Phase: Phase 1
• Start date: August 15, 2017
• Est. completion date: September 14, 2018

Study information

• Verified date: August 2021
• Source: Monteris Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Device:
• NeuroBlate System
Laser Interstitial Thermal Therapy

Drug:
• Radiation therapy and temozolomide
Radiation therapy and temozolomide

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Washington University	Saint Louis	Missouri
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Monteris Medical

Country where clinical trial is conducted

United States, 

Outcome

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