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Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma

ConditionGBM
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cincinnati

About this trial

This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male/female patients ≥ 18 years of age.

Histologically confirmed glioblastoma at original diagnosis, recurrent after prior radiotherapy and temozolomide chemotherapy.

Must have measurable disease ≥ 10mm (according to RANO criteria) .

Interval since completion of radiation treatment (including radiation at original diagnosis and/or radiation for recurrent disease) ≥ 12 weeks.

Disqualifiers

1) Previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR), including bevacizumab.

Trial design

Design model

Single group

Treatments tested in this trial

  • NaviFUS System

    Device

    The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB. The NaviFUS System is indicated for use to enhance the permeability of conventionally administered therapeutic agents into targeted brain tissue to enhance their therapeutic effects.

  • Lumason

    Drug

    The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB.

  • Bevacizumab

    Drug

    In this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: NaviFUS + bevacizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Safety -assessed using -Device-related Adverse Events (AEs) reported

The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported \[Time Frame: Through study completion, up to 24 weeks\].

Time frame
Through study completion, up to 24 weeks

Secondary outcomes

1

Progression-free survival at 6-months and 12-months as determined using the Radiologic Assessment in Neuro-Oncology (RANO) criteria.

The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. 1\) Progression-free survival at 6-months and 12-months as determined using the Radiologic Assessment in Neuro-Oncology (RANO) criteria.

Time frame
Pr6-months and 12-months
2

Median PFS at 6-months and 12-months as determined using the RANO criteria

The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. 2\) Median PFS at 6-months and 12-months as determined using the RANO criteria

Time frame
6-months and 12-months
3

Objective response rate (ORR) as determined using the RANO criteria at Week 8, 16, and 24.

The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. 3\) Objective response rate (ORR) as determined using the RANO criteria at Week 8, 16, and 24.

Time frame
Week 8, 16, and 24.
4

Overall survival (OS) at 6 & 12 months.

The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. 4\) Overall survival (OS) at 6 \& 12 months.

Time frame
6 & 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cincinnati

Lead sponsor

NaviFUS Corporation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: