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

June 20, 2019 updated by: NaviFUS Corporation

A FIH Feasibility Study to Evaluate the Safety of Transient Disruption of Blood-brain Barrier in Recurrent Glioblastoma Multiforme (GBM) Patients Using NaviFUS System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and severity of AE
Time Frame: 45 days
Safety of transient opening of the BBB by using the NaviFUS System
45 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
7 days post-FUS
Quantify the BBB disruption following BBB disruption by the NaviFUS System
Time Frame: 1 day
Dynamic T1 contrast-enhanced MRI
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NaviFUS Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kuo-Chen Wei, M.D., Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NF-2017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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