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Safety of BBB Disruption Using NaviFUS System in Recurrent Glioblastoma Multiforme (GBM) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03626896
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : June 21, 2019
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
NaviFUS Corporation

Brief Summary:
This study is to evaluate the safety and find the tolerated ultrasound dose of transient opening of the blood-brain barrier (BBB) by using the NaviFUS System in recurrent GBM patients.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Brain Tumor Glioblastoma Glioma Neoplasms Neoplasms, Nerve Tissue Device: NaviFUS System Not Applicable

Detailed Description:
This is a feasibility, open-label, single-arm, and dose escalation study. Eligible patients will be enrolled through the process of informed consent. Patients will be assigned into different dose groups generated from the NaviFUS System to transiently open the BBB in patients with recurrent GBM who will undergo surgery within 2 weeks. The focused ultrasound (FUS) dose is selected based on the results of pre-clinical Good Laboratory Practice (GLP) safety studies as well as other non-GLP primate studies. This study will evaluate the safety and the tolerated ultrasound dose of temporary disruption of the BBB in patients with recurrent GBM. To find the tolerated ultrasound dose, the data and safety monitoring board (DSMB) will review the study data and provide the recommendations regarding continuation, termination, or other modifications of the study based on evaluation of observed adverse effects of the intervention. The extent and magnitude of BBB opening will be evaluated using of dynamic contrast-enhanced MRI (DCE-MRI).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A FIH Feasibility Study to Evaluate the Safety of Transient Disruption of Blood-brain Barrier in Recurrent Glioblastoma Multiforme (GBM) Patients Using NaviFUS System
Actual Study Start Date : August 17, 2018
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NaviFUS System
NaviFUS System: dose escalation focus ultrasound to transiently disrupt BBB
Device: NaviFUS System
BBB Disruption by FUS in recurrent GBM Other Name: Neuronavigation-guided focus ultrasound system

Primary Outcome Measures :
  1. Number and severity of AE [ Time Frame: 45 days ]
    Safety of transient opening of the BBB by using the NaviFUS System

Secondary Outcome Measures :
  1. Tolerated dose of FUS with the NaviFUS System for transient disruption of the BBB [ Time Frame: 7 days post-FUS ]
    Dose escalation study using FUS

  2. Quantify the BBB disruption following BBB disruption by the NaviFUS System [ Time Frame: 1 day ]
    Dynamic T1 contrast-enhanced MRI

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed with recurrent GBM and will undergo surgery
  • Able to give written informed consent for the participation in the trial
  • Adult male/female patients > 20 years of age
  • Patients if already on radiotherapy, a gap of 7 days shall be maintained between the last day of radiotherapy and the day of screening
  • Patients if already on the steroids treatment, then should be on a stable dose of steroids for at least 7 days prior to screening
  • Body mass index (BMI) ≥17 kg / m2
  • Patients with life expectancy ≥ 3 months
  • Able to comply with study requirements in the opinion of the investigator
  • Adequate hepatic, renal, coagulation, and hematopoietic function

    • Hemoglobin ≥ 10 g/dL
    • Platelets ≥ 100,000/mm3
    • Neutrophils ≥ 1,500/mm3
    • Normal creatinine clearance ≥ 50mL/min
    • Alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
    • Aspartate transaminase (AST) < 3 x ULN
    • Prothrombin time ≤ 1.2 x ULN
    • International Normalized Ratio (INR) < 1.5
    • Bilirubin < 2 x ULN
  • Patients with the ROI for FUS exposure are located close to the cortex with at least 20 mm distance beneath the skull bone and the ROI is not in the deep center brain with crucial brain functions, such as in the region of brain stem, or motor or speech regions
  • The Karnofsky performance status (KPS) in the patient must be > 60

Exclusion Criteria:

  • Patients at screening visit have arteriovenous malformation (AVM) or cerebral aneurysm
  • Use of any recreational drugs or history of drug addiction
  • Pregnant or breast-feeding women
  • The receipt of an investigational drug, or participation in a drug research study within a period of one month prior to the first FUS exposure
  • Known sensitivity/allergy to MRI contrast agents, CT contrast agents, SonoVue®, or any of its components
  • Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
  • Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
  • Patients who have hemorrhage or cyst within the ROI
  • Severe hypertension at screening (diastolic blood pressure > 100 mmHg on medication)
  • Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week prior to study treatment or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month prior to study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03626896

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Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 33305
Sponsors and Collaborators
NaviFUS Corporation
Chang Gung Memorial Hospital
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Principal Investigator: Kuo-Chen Wei, M.D. Chang Gung Memorial Hospital
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Responsible Party: NaviFUS Corporation Identifier: NCT03626896    
Other Study ID Numbers: NF-2017-01
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NaviFUS Corporation:
BBB disruption
NaviFUS System
Focused Ultrasound
Additional relevant MeSH terms:
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Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial