Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioblastoma

Glioma

Brain Neoplasms

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Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Using Exablate Model 4000 Type 2 for liquid biopsy in subjects with Glioblastoma

BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening

Focused Ultrasound (Exablate Model 4000)

Julia Zhu

Matt Hibert

Karolin Markarian

Richard Everson, MD

Stephanie Lewis

John de Groot, M.D.

Phuong Deleyrolle, RN

Justin Hilliard, MD

Daylen Santana

Manmeet Ahluwalia

Kathryn Hudson

Yarema Bezchlibnyk, MD

Kaitlyn Henry

Graeme Woodworth, MD

Jessica Wollet

Jordina Rincon Torroella

Adam Loudermilk

Terence Burns, MD, PhD

Cathryn Lapierre

Shannon Ciprut

Alon Mogilner

Stevie Threatt

Gerald Grant, MD

Vida Rhodes

Bhavya Shah, MD

Sharon Ji

Jeffrey Weinberg, MD

Kiley Everson, RN, BSN

Christopher Cifarelli, MD, PhD

Maheleth Llinas

Nir Lipsman

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors

This is a prospective, multi-center, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for liquid biopsy in subjects with suspected Glioblastoma brain tumors. The study will be conducted at up to 25 centers in the US.

Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE

To demonstrate there is a correlation between patterns obtained in the panel of biomarkers evaluated in the resected tumor tissue and/or biopsy and blood sample collected post-BBBD

To demonstrate that there is at least a 2-fold increase in circulating free DNA following blood brain barrier disruption (BBBD)

InSightec

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors	NCT05383872	Glioblastoma Glioma Liquid Biopsy	Focused Ultraso...	18 Years - 80 Years	InSightec
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors	NCT05383872	Glioblastoma Glioma Liquid Biopsy	Focused Ultraso...	18 Years - 80 Years	InSightec
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors	NCT05383872	Glioblastoma Glioma Liquid Biopsy	Focused Ultraso...	18 Years - 80 Years	InSightec
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors	NCT05383872	Glioblastoma Glioma Liquid Biopsy	Focused Ultraso...	18 Years - 80 Years	InSightec

Spots Global Cancer Trial Database for focused ultrasound (exablate model 4000)