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
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
Treatments tested in this trial
- NaviFUS System
- Lumason
- Bevacizumab
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Cincinnati
Lead sponsor
NaviFUS Corporation
Collaborator
Source ClinicalTrials.gov