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

NCT04988750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-13

No results posted yet for this study

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

DEVICE

NaviFUS System

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

Sponsors & Collaborators

  • NaviFUS Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-23
Primary Completion
2023-06-07
Completion
2025-06-16

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04988750 on ClinicalTrials.gov