Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM

Titre officiel

Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy

Sommaire:

Cette étude vise à évaluer l’innocuité et la faisabilité du système ExAblate 4000 de type 2 comme outil d’ouverture de la barrière hémato-encéphalique (OBHE) chez des sujets atteints d’un glioblastome récurrent qui prennent du carboplatine en monothérapie.

Description de l'essai

Primary Outcome:

• Occurrence of Adverse Events
• Contrast intensity on MR imaging

This is a Phase 1/2, open-label, prospective, multi-centre, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.

Voir cet essai sur ClinicalTrials.gov