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Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients

NCT04446416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-09

No results posted yet for this study

Summary

This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients. The BEV is the best physician's choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial Hospital. Eligible patients will be enrolled through the process of informed consent.

Conditions

Interventions

DEVICE

NaviFUS System

Open the BBB using focused ultrasound and contrast agent SonoVue®

DRUG

Bevacizumab

An anti-angiogenic agent to block tumor growth

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • NaviFUS Corporation

    lead INDUSTRY

Principal Investigators

  • Kuo-Chen Wei, M.D. · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2022-09-30
Completion
2023-08-04

Countries

  • Taiwan

Study Locations

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Entities

Drugs
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 NCT04446416 on ClinicalTrials.gov