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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

6

Phase

  • 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

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
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

What is the study measuring?

Primary Outcome Measures

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

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

NaviFUS Corporation

Collaborators

Chang Gung Memorial Hospital

Investigators

  • 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)

August 17, 2018

Primary Completion (Actual)

May 20, 2019

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Glioma

Clinical Trials on NaviFUS System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe