ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma

NCT03322813 | Suspended DMC FDA Device

• 1 other identifier: BT004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB.

Conditions

Glioma

Keywords

Glioblastoma; Blood Brain Barrier; BBB; ExAblate; Blood Brain Barrier Disruption; Infiltrating glioma

Outcome Measures

Primary Outcomes (1)

• Device and procedure related adverse events

  The number and severity of device and BBBD procedure related adverse events will be evaluated.

  At the time of the ExAblate MRgFUS procedure

Secondary Outcomes (1)

• Feasibility of BBB disruption

  At the time of the ExAblate MRgFUS procedure and 24 hours post-procedure

Study Arms (1)

ExAblate 4000 - Type 2

EXPERIMENTAL

ExAblate BBBD

Device: ExAblate 4000 - Type 2

Interventions

ExAblate 4000 - Type 2 DEVICE

Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma undergoing resection

Also known as: ExAblate BBBD

ExAblate 4000 - Type 2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female between 21-85 years of age
• Able and willing to give informed consent
• Subjects with suspected infiltrating glioma on pre-operative brain imaging scans including non-enhancing MRI tumor components in non-eloquent regions that are within the planned surgical resection volume
• Surgical area targeted for ExAblate treatment (i.e. prescribed Region of Treatment) ≤30 cm3; planned surgical resection volume may exceed the targeted treatment volume
• Karnofsky Performance Score 70-100
• Able to communicate sensations during the ExAblate® BBBD procedure

You may not qualify if:

• MRI or clinical findings of:
• Active or chronic infection(s) or inflammatory processes
• Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macrohemorrhages
• Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
• Evidence of tumor-related calcification, cyst, or hemorrhage
• Midline shift of \>10mm or evidence of subfalcine, uncal, or tonsillar herniation on pre-operative imaging
• More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
• Clips, shunts, or any metallic implanted objects in the skull or the brain or the presence of unknown MR unsafe devices anywhere within the body
• Significant cardiac disease or unstable hemodynamic status
• Uncontrolled hypertension (systolic \> 150 and diastolic BP \> 100 on medication)
• Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
• History of a liver disease, bleeding disorder, coagulopathy or a history of spontaneous hemorrhage
• Abnormal coagulation profile (Platelets \< 100,000), PT (\>14) or PTT (\>36), and INR \> 1.3
• Lacunar lesions or evidence of increased risk of bleeding
• Known cerebral or systemic vasculopathy

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Anastasiadis P, Gandhi D, Guo Y, Ahmed AK, Bentzen SM, Arvanitis C, Woodworth GF. Localized blood-brain barrier opening in infiltrating gliomas with MRI-guided acoustic emissions-controlled focused ultrasound. Proc Natl Acad Sci U S A. 2021 Sep 14;118(37):e2103280118. doi: 10.1073/pnas.2103280118.

  PMID: 34504017 DERIVED

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Officials

• Graeme Woodworth, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 26, 2017
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (1)