Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Subjects will undergo ExAblate BBBD prior to their standard of care tumor removal

Subjects will undergo their standard of care tumor removal

Blood brain barrier disruption using ExAblate Type 2 device using microbubble resonators

Exablate BBBD

Graeme Woodworth, MD

The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators (Exablate Test Arm) to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming, and thereby 'marking', regions of infiltrating gliomas prior to planned surgical resection, for the purpose of improving tumor visualization during the surgery to achieve a greater proportion of subjects who receive a Gross Total Resection (GTR) per plan compared to those not undergoing a BBBD procedure prior to resection (Control Arm).

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a 2:1 ratio to Exablate Test Arm and to Control Arm, respectively. The following assessments will occur:

1. Pre-surgical planning and Post-surgical visit MRI exams with and without contrast will be collected for evaluation by the study core lab; Any return to surgery for additional resection will be captured
2. All subjects will be seen at \~Week 2, and \~4-Weeks post resection for physical and neurological exams and to assess for complications or adverse events. These visits should coincide with standard (Neuro-oncology) care following resection.
3. Long-term outcomes will be collected during standard of care Neuro-oncology care follow-up visits for up to 2 years post resection; standard of care MRIs and RANO assessments will be collected.

Independent Reviewers (neurosurgeon/neuroradiologist), functioning as an Imaging Review Core Lab, will be blinded to the treatment assignment.

Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma

A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma

Collection of blood for evaluation of circulating tumor biomarkers (e.g. circulating tumor DNA \[ctDNA\])

Safety of the Exablate BBBD procedure will be evaluated by patient examination and post-procedure MRI exams assessing changes in the treated region. Adverse events will be reported by the Investigator and monitored in both treatment arms.

The proportion of subjects in whom a gross total resection (actual versus planned) is achieved as measured on post-operative imaging compared to pre-resection imaging

Confirmation that new BBBD by contrast enhancement in a previously non-enhancing area overlies the intended target for BBBD. (ExAblate arm only)

Comparison of the Return Rate between the two treatment arms.

InSightec

Symptoms and General Pathology

Recurrence

Glioblastoma

Astrocytoma

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to carboplatin administration.

BBB opening via Exablate Neuro Type 2 system to deliver carboplatin

Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain

The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

This is a Phase 1/2, open-label, prospective, multi-center, 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.

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

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

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

BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging

Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.

BBB opening via Exablate Neuro Type 2 system with microbubble resonators.

This is a Phase 1/2, open-label, prospective, multi-center, 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 with microbubble resonators. 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.

Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy

Assessment of Safety and Feasibility of Exablate Type 2 for Blood-Brain Barrier Disruption (BBBD) With Microbubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma	NCT04667715	Glioma	Exablate BBBD	21 Years - 85 Years	InSightec
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM	NCT04440358	Recurrent Gliob...	Exablate BBBD Carboplatin	18 Years - 80 Years	InSightec
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM	NCT04440358	Recurrent Gliob...	Exablate BBBD Carboplatin	18 Years - 80 Years	InSightec
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy	NCT04417088	Recurrent Gliob...	Carboplatin Exablate BBBD	18 Years - 80 Years	InSightec

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