NCT04988750

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

Completed NA Last updated 13 April 2026

What this trial tests

NA trial testing NaviFUS System in Recurrent Glioblastoma in 7 participants. Completed in 16 June 2025.

Timeline

23 May 2021

Primary endpoint
7 June 2023

16 June 2025

Quick facts

Lead sponsor	NaviFUS Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	23 May 2021
Primary completion	7 June 2023
Estimated completion	16 June 2025
Sites	1 location across Taiwan

Drugs / interventions tested

• NaviFUS System

Conditions studied

• Recurrent Glioblastoma — all drugs for Recurrent Glioblastoma →
• High-Grade Glioma (WHO III-IV) — all drugs for High-Grade Glioma (WHO III-IV) →
• Brain Tumor Recurrent — all drugs for Brain Tumor Recurrent →
• Brain Tumor Adult — all drugs for Brain Tumor Adult →

Sponsor

NaviFUS Corporation — full company profile →

Who can join

20 and older, any sex, with Recurrent Glioblastoma or High-Grade Glioma (WHO III-IV). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging therapies for glioblastoma: current state and future directions.
   Rong L, Li N, Zhang Z. · · 2022 · cited 351× · PMID 35428347 · DOI 10.1186/s13046-022-02349-7
2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
3. Advances in local therapy for glioblastoma - taking the fight to the tumour.
   van Solinge TS, Nieland L, Chiocca EA, Broekman MLD. · · 2022 · cited 219× · PMID 35277681 · DOI 10.1038/s41582-022-00621-0
4. Glioblastoma Therapy: Past, Present and Future.
   Obrador E, Moreno-Murciano P, Oriol-Caballo M, López-Blanch R, et al · · 2024 · cited 147× · PMID 38473776 · DOI 10.3390/ijms25052529
5. Strategies to Improve Drug Delivery Across the Blood-Brain Barrier for Glioblastoma.
   Narsinh KH, Perez E, Haddad AF, Young JS, et al · · 2024 · cited 53× · PMID 38578405 · DOI 10.1007/s11910-024-01338-x
6. Focused ultrasound-mediated enhancement of blood-brain barrier permeability for brain tumor treatment: a systematic review of clinical trials.
   Zhu H, Allwin C, Bassous MG, Pouliopoulos AN. · · 2024 · cited 34× · PMID 39207625 · DOI 10.1007/s11060-024-04795-z
7. Overview of Therapeutic Ultrasound Applications and Safety Considerations: 2024 Update.
   Bader KB, Padilla F, Haworth KJ, Ellens N, et al · · 2025 · cited 23× · PMID 39526313 · DOI 10.1002/jum.16611
8. Device-assisted strategies for drug delivery across the blood-brain barrier to treat glioblastoma.
   Mokarram N, Case A, Hossainy NN, Lyon JG, et al · · 2025 · cited 17× · PMID 39790893 · DOI 10.1038/s43246-024-00721-y