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Recurrent GlioblastomaNCT04988750

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

A study testing NaviFUS System in people with Recurrent Glioblastoma and High-Grade Glioma (WHO III-IV), 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 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. Read more about this study

Who is it for?
Ages 20 years and older
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
7 participants
Where
1 siteTaiwan
Study dates
23 May 2021to 16 Jun 2025
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

  • Adult male/female patients ≥ 20 years of age.
  • Patients who meet one of the following criteria are considered eligible: (1) Histologically proven Grade IV glioma patients that is recurrent following standard radiation therapy (RT) and temozolomide and the second recurrent after prior treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab) administration (bevacizumab failure).
  • Histologically proven Grade III glioma patients that is recurrent following radiation therapy (RT) and/or temozolomide, who need re-RT treatment based on the physician's judgment.
  • 3. Patients if already on the steroids then should be on a stable or decreasing dose of steroids for at least 7 days prior to study treatment.
  • 4. Minimum interval since completion of radiation treatment is 12 weeks. The targeted region of the radiation treatment must be the same as the targeted region in the study according to the investigator's decision.
  • 5. At the time of study treatment, minimum interval since last drug therapy:
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  • 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen), daily chemotherapy (e.g., metronomic temozolomide, cytoxan) or targeted therapies administered daily (e.g., gleevec, tarceva)
  • 4 weeks since last cytotoxic therapy or inhibitor of VEGF or VEGFR (e.g., bevacizumab)
  • 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., carmustine [BCNU])
  • 6. Body mass index (BMI) ≥17 kg/ m2.
  • 7. Eastern Cooperative Oncology Group (ECOG) score ≤ 3.
  • 8. Patients with life expectancy ≥ 12 weeks.
  • 9. Adequate hepatic, renal, coagulation, and hematopoietic function.
  • Hemoglobin ≥ 8 g/dL
  • Platelets ≥ 100,000/mm3
  • Neutrophils ≥ 1,500/mm3
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Alanine transaminase (ALT) < 3 x ULN
  • Aspartate transaminase (AST) < 3 x ULN
  • Prothrombin time ≤ 1.2 x ULN
  • International Normalized Ratio (INR) < 1.5
  • Bilirubin < 2 x ULN
  • 10. Patients with the region of interest (ROI) for FUS exposure are located at least 30 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.
  • 11. Patients with the potential for pregnancy and their partner must agree to follow acceptable birth control methods to avoid conception. Female patients of child-bearing potential must have a negative pregnancy test.
  • 12. Able to give written informed consent for the participation in the trial and comply with study requirements in the opinion of the investigator.

Who cannot join

  • Patients with implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
  • Patients with meningeal metastasis, intracranial stroke within the previous 6 months, congestive heart failure, unstable angina, cardiac arrhythmia, unstable cardiac status, and uncontrolled seizure activity.
  • Patients with known HIV, however, that HIV testing is not required for entry into this study.
  • Any patient requiring supplemental oxygen therapy.
  • Use of any recreational drugs or history of drug addiction.
  • Pregnant or breast-feeding women.
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  • The receipt of an investigational drug within a period of 28 days prior to the first FUS exposure.
  • Known sensitivity/allergy to PET tracers, O-(2- [18F]fluoroethyl)- L-tyrosine (FET) or 2-Deoxy-2-[18F]fluoro-D-glucose (FDG); Magnetic Resonance Imaging (MRI) contrast agents, Dotarem; Computer Tomography (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 acute hemorrhage within the ROI.
  • Major surgery or significant traumatic injury that has not been recovered from by 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to screening, or who have not recovered from side effects of such procedure or injury.
  • Patients who have coagulopathy or risk factors for bleeding.
  • Receiving anticoagulants or antiplatelet drugs within one week before study entry.
  • Receiving medications known to increase the risk of bleeding within one month before study entry (e.g., bevacizumab).
  • Contraindications to MRI, including but not limited to metallic implants and claustrophobia.
  • Patients with severe hypertension (defined as systolic blood pressure > 180 mmHg or diastolic blood pressure >100 mmHg).
  • Patients with cardiac shunt.
  • Patients with anticancer therapy-related adverse events which are unrecovered/unresolved to baseline or at grade 1 in severity.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Medical Foundation

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: 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

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.

Being tested
NaviFUS System
Keywords
NaviFUS System, Focused ultrasound, Low-intensity Focused Ultrasound, Radiosensitization
Medical subject headings
Glioblastoma, Glioma, Brain Neoplasms

What participants receive

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

  • NaviFUS SystemDevice

    Also called Focused ultrasound, Low-Intensity Focused Ultrasound

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

Study groups in NCT04988750
Study groupRoleWhat they receive
FUS + re-RT or FUS + SRSExperimentalThe 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.
Receives: Device: NaviFUS System

What is being measured

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

  1. Adverse events

    Safety

    Measured: up to 6 months

Secondary outcomes (6)

  1. Objective response rate (ORR)

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

    Measured: Up to 6 months

  2. Progression-free survival (PFS)

    PFS and median PFS based on RANO criteria

    Measured: Up to 6 months

  3. Overall survival (OS)

    OS and median OS

    Measured: Up to 6 months

  4. Corticosteroid consumption

    Compared the steroid dosage before treatment and after treatment

    Measured: Up to 6 months

  5. European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30)

    Compared the Quality of Life before treatment and after treatment. The higher summary scores reflect better overall health-related quality of life.

    Measured: Up to 6 months

  6. European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer questionnaire (BN20)

    Compared the Quality of Life before treatment and after treatment. The higher summary scores reflect worse symptoms/problems.

    Measured: Up to 6 months

Timeline

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

  1. First posted3 Aug 2021
  2. Study start23 May 2021
  3. Primary completion7 Jun 2023
  4. Study completion16 Jun 2025

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04988750
Sponsor's protocol ID
NF-2020-01
Status last verified
Apr 2026
First submitted
2 Jul 2021
Last updated
13 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen KT, Chai WY, Lin YJ, Lin CJ, Chen PY, Tsai HC, Huang CY, Kuo JS, Liu HL, Wei KC. Neuronavigation-guided focused ultrasound for transcranial blood-brain barrier opening and immunostimulation in brain tumors. Sci Adv. 2021 Feb 5;7(6):eabd0772. doi: 10.1126/sciadv.abd0772. Print 2021 Feb.

    PubMed 33547073

  • Chen KT, Huang CY, Pai PC, Yang WC, Tseng CK, Tsai HC, Li JC, Chuang CC, Hsu PW, Lee CC, Toh CH, Liu HL, Wei KC. Correction to: Focused ultrasound combined with radiotherapy for malignant brain tumor: a preclinical and clinical study. J Neurooncol. 2024 Apr;167(2):371. doi: 10.1007/s11060-024-04671-w. No abstract available.

    PubMed 38598089

Questions about this trial

What is this clinical trial studying?

A study testing NaviFUS System in people with Recurrent Glioblastoma and High-Grade Glioma (WHO III-IV), 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 25 inclusion and 19 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 13 Apr 2026. 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?

Adverse events (time frame: up to 6 months). 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 NCT04988750, which also lists 2 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 13 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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