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

  • STATUS
    Recruiting
  • End date
    Nov 7, 2023
  • participants needed
    30
  • sponsor
    InSightec
Updated on 7 June 2021

Summary

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.

Description

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.

Details
Condition Recurrent Glioblastoma
Treatment carboplatin, ExAblate BBBD
Clinical Study IdentifierNCT04417088
SponsorInSightec
Last Modified on7 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be between 18-80 years old
Histologically confirmed glioblastoma
Planned for Carboplatin monotherapy
Be willing and able to provided written informed consent/asent
Tumor progression after first line chemo radiation
Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy
Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception
Able to communicate verbally

Exclusion Criteria

Acute intracranial hemorrhage
Ferrous metallic implanted objects in the skull or brain
Prior toxicity with carboplatin chemotherapy
Women who are pregnant or breastfeeding
Cerebellar spinal cord or brain stem tumor
Known active Hepatitis B or Hepatitis C or HIV
Significant depression not adequately controlled
Has previously received anti-VEGF or anti-VEGF agents like Avastin
Cardiac disease or unstable hemodynamics
Severe hypertension
History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
Active drug or alcohol use disorder
Known sensitivity to gadolinium-based contrast agents
Known sensitivity or contraindications to ultrasound contrast agent or perflutren
Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices
Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication
Severely impaired renal function
Right to left or bi-directional cardiac shunt
Cranial or systemic infection requiring antibiotics
Known additional malignancy that is progression or require active treatment
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