Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

The SRS treatment will be administered for 3 consecutive days (one fraction of 7-9 Gy per day; total dose 21-27 Gy), including SRS treatment 1 (SRS 1), SRS treatment 2 (SRS 2), and SRS treatment 3 (SRS 3). At the SRS 1 and SRS 3, the patients will be shaved their hair at first, and the patient registration will be performed for the neuronavigation system according to the instruction of the system.

cRT will be administered for 5 consecutive days within one week, and a full course is two weeks (one fraction of 3-4 Gy per day; total dose: 30-40 Gy), including cRT treatment 1 to cRT treatment 10 (cRT 1-cRT 10). At the cRT 1, cRT 3, cRT 6, and cRT 8, the patients will be shaved their hair at first, and the patient registration will be performed for the neuronavigation system according to the instruction of the system.

Using the neuronavigator to precisely guide the ultrasound energy to brain tissues in real-time and intraoperatively.

NaviFUS System

Sheang-Tze Fung, Ph.D.

Kuo-Chen Wei, MD

This is an open label, single arm, prospective, and pilot study. Eligible patients will be enrolled after acquiring the signed informed consent and then will receive the treatment of re-RT combined with FUS (FUS + re-RT) on an outpatient basis. The re-RT in FUS + re-RT treatment will include fractioned stereotactic radiosurgery (SRS) treatment (FUS + SRS) or conventional radiotherapy (cRT) treatment (FUS + cRT). The treatment of SRS or cRT treatment given to patients is determined by the investigator depending on the volume and location of the treatment region.

Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients

An Open Label, Prospective, Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Combination of Focused Ultrasound With Re-irradiation for the Treatment Patients With Recurrent Glioblastoma Multiforme Using NaviFUS System

ORR based on Response Assessment in Neuro-Oncology (RANO) criteria

PFS and median PFS based on RANO criteria

Compared the steroid dosage before treatment and after treatment

NaviFUS Corporation

Nervous System Diseases

Brain Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Angiogenesis Inhibitors

Antineoplastic Agents, Immunological

Growth Inhibitors

Open the BBB using focused ultrasound and microbubble

Lumason

An anti-angiogenic agent to block tumor growth

Arthur Lung, Ph.D.

Jason Sheehan, M.D., Ph.D.

This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.

The study aims to demonstrate the high safety profile and effectiveness of BEV+FUS-MB targeted therapy for brain tumors.

Any patient with a histological diagnosis of GBM who meets all of the specific eligibility criteria may participate in this study by signing informed consent in person or through their legal representative. Eligible patients will undergo a 2-week baseline observation screening period.

Up to 10 eligible patients will be enrolled in this study. Eligible patients will follow the standard operating procedures of BEV (10 mg/kg intravenous (IV) infusion over 30-90 minutes). After at least 30 minutes, patients will be administered microbubbles (MB) (Lumason®) at a dose of 0.1 mL/kg, along with optimal ultrasound exposure doses determined by the acoustic emission feedback FUS power control algorithm of the NaviFUS System. The treatment will be administered every 2 weeks up to 34 weeks or until evidence of progression disease (PD), intolerable toxicity precluding further treatment, non-compliance with study follow-up, or withdrawal of consent, whichever occurs first.

Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

A Prospective, Open-Label, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

The incidence and severity of AEs associated with FUS-MB+BEV treatment in patients with rGBM

PFS-6 is the proportion of patients who remain progression-free at the 6-month time point, as determined by Response Assessment in Neuro-Oncology (RANO) Criteria, from the time of their first treatment.

PFS is defined as the time from the date of first treatment to the earliest date of the first objective documentation of radiographic progression disease based on RANO Criteria, death, or last known follow-up due to any cause whichever occurs first. PFS will be followed continuously till the End-of-Study.

One-year survival rate is the proportion of patients who remain alive at the one-year time point from the time of their first treatment.

OS is defined as the time from the date of first treatment to the earliest date of death or last known follow-up due to any cause whichever occurs first. OS will be followed continuously while subjects are on study and via phone interviews every 3 months during the survival follow-up phase of the study.

ORR is defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) based on a combination of imaging and clinical features as assessed by the RANO Criteria.

CBR is defined as the proportion of patients who achieved an overall response of CR, PR, or SD based on a combination of imaging and clinical features as assessed by the RANO Criteria.

Local disease control is defined as the proportion of patients who achieved a CR, PR, or SD within the planning target tumor lesion, as assessed by the RANO Criteria.

Changes in corticosteroid usage will be compared to baseline.

The standardized and validated European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) and brain cancer questionnaire (QLQ-BN20, assessment specific to brain neoplasm) will be assessed at baseline and throughout treatment period. The changes in QoL during treatment will be compared to baseline. QoL is assessed based on the cancer or brain tumor patient's subjective evaluation of their current status, the presence or absence of the specific symptoms, and their overall general health.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients	NCT04988750	Recurrent Gliob...	NaviFUS System	20 Years -	NaviFUS Corporation
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)	NCT06329570	Glioblastoma Mu... Glioblastoma Glioma Brain Tumor Neoplasms Neoplasms, Nerv...	NaviFUS System Lumason Bevacizumab	18 Years -	NaviFUS Corporation

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