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Glioblastoma MultiformeNCT03626896

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

A study testing NaviFUS System in people with Glioblastoma Multiforme and Brain Tumor, run by NaviFUS Corporation at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Glioblastoma Multiforme, Brain Tumor, Glioblastoma
What is being tested?
NaviFUS System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteTaiwan
Study dates
17 Aug 2018to 19 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33305

Other trials in Taiwan

About this study

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

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.

Read the 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).

Being tested
NaviFUS System
Keywords
BBB disruption, NaviFUS System, Focused Ultrasound, GBM
Medical subject headings
Glioblastoma, Brain Neoplasms, Glioma, Neoplasms, Neoplasms, Nerve Tissue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NaviFUS SystemDevice

    BBB Disruption by FUS in recurrent GBM Other Name: Neuronavigation-guided focus ultrasound system

Study groups in NCT03626896
Study groupRoleWhat they receive
NaviFUS SystemExperimentalNaviFUS System: dose escalation focus ultrasound to transiently disrupt BBB
Receives: Device: NaviFUS System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and severity of AE

    Safety of transient opening of the BBB by using the NaviFUS System

    Measured: 45 days

Secondary outcomes (2)

  1. Tolerated dose of FUS with the NaviFUS System for transient disruption of the BBB

    Dose escalation study using FUS

    Measured: 7 days post-FUS

  2. Quantify the BBB disruption following BBB disruption by the NaviFUS System

    Dynamic T1 contrast-enhanced MRI

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2018
  2. Study start17 Aug 2018
  3. Primary completion20 May 2019
  4. Study completion19 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03626896
Sponsor's protocol ID
NF-2017-01
Status last verified
Aug 2018
First submitted
7 Aug 2018
Last updated
21 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Publications

  • Wei KC, Tsai HC, Lu YJ, Yang HW, Hua MY, Wu MF, Chen PY, Huang CY, Yen TC, Liu HL. Neuronavigation-guided focused ultrasound-induced blood-brain barrier opening: a preliminary study in swine. AJNR Am J Neuroradiol. 2013 Jan;34(1):115-20. doi: 10.3174/ajnr.A3150. Epub 2012 Jun 21.

    PubMed 22723060

  • McDannold N, Zhang Y, Vykhodtseva N. Blood-brain barrier disruption and vascular damage induced by ultrasound bursts combined with microbubbles can be influenced by choice of anesthesia protocol. Ultrasound Med Biol. 2011 Aug;37(8):1259-70. doi: 10.1016/j.ultrasmedbio.2011.04.019. Epub 2011 Jun 8.

    PubMed 21645965

  • Liu HL, Wai YY, Chen WS, Chen JC, Hsu PH, Wu XY, Huang WC, Yen TC, Wang JJ. Hemorrhage detection during focused-ultrasound induced blood-brain-barrier opening by using susceptibility-weighted magnetic resonance imaging. Ultrasound Med Biol. 2008 Apr;34(4):598-606. doi: 10.1016/j.ultrasmedbio.2008.01.011. Epub 2008 Mar 3.

    PubMed 18313204

  • Hynynen K, McDannold N, Sheikov NA, Jolesz FA, Vykhodtseva N. Local and reversible blood-brain barrier disruption by noninvasive focused ultrasound at frequencies suitable for trans-skull sonications. Neuroimage. 2005 Jan 1;24(1):12-20. doi: 10.1016/j.neuroimage.2004.06.046.

    PubMed 15588592

  • Wei KC, Chu PC, Wang HY, Huang CY, Chen PY, Tsai HC, Lu YJ, Lee PY, Tseng IC, Feng LY, Hsu PW, Yen TC, Liu HL. Focused ultrasound-induced blood-brain barrier opening to enhance temozolomide delivery for glioblastoma treatment: a preclinical study. PLoS One. 2013;8(3):e58995. doi: 10.1371/journal.pone.0058995. Epub 2013 Mar 19.

    PubMed 23527068

Questions about this trial

What is this clinical trial studying?

A study testing NaviFUS System in people with Glioblastoma Multiforme and Brain Tumor, run by NaviFUS Corporation at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and severity of AE (time frame: 45 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03626896, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.

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