Trials / Completed
CompletedNCT04988750
Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- NaviFUS Corporation · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
- Recurrent Glioblastoma
- High-Grade Glioma (WHO III-IV)
- Brain Tumor Recurrent
- Brain Tumor Adult
- Brain Tumor, Adult: Glioblastoma
- Brain Tumor, Recurrent
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NaviFUS System | Using the neuronavigator to precisely guide the ultrasound energy to brain tissues in real-time and intraoperatively. |
Timeline
- Start date
- 2021-05-23
- Primary completion
- 2023-06-07
- Completion
- 2025-06-16
- First posted
- 2021-08-03
- Last updated
- 2026-04-13
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04988750. Inclusion in this directory is not an endorsement.