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

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ClinicalTrials.gov Identifier: NCT04417088
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: Carboplatin Device: Exablate BBBD Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arm Intervention/treatment
Experimental: Exablate BBBD with 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.
Drug: Carboplatin
Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain

Device: Exablate BBBD
BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
Other Name: Exablate Neuro




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Through study completion, an average of 12 months ]
    All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.

  2. Contrast intensity on MR imaging [ Time Frame: Immediately after Exablate BBBD procedure ]
    BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417088


Contacts
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Contact: Julia Zhu 469-607-0491 juliaz@insightec.com
Contact: Patrice Horwath patriceh@insightec.com

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Hari Priya Yerraballa, MBBS    650-724-9363    yhpriya@stanford.edu   
Principal Investigator: Seema Nagpal, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kaitlyn Henry    410-328-0939    KHenry@som.umaryland.edu   
Principal Investigator: Graeme Woodworth, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anna Ball    617-732-6992    aball@bwh.harvard.edu   
Contact: Ana Montalvo Landivar    754-422-3432    amontalvolandivar@bwh.harvard.edu   
Principal Investigator: Alexandra Golby, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kathy Robinson    216-445-8624    robinsk2@ccf.org   
Principal Investigator: Glen Stevens, DO, PhD         
Sponsors and Collaborators
InSightec
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT04417088    
Other Study ID Numbers: BT009
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by InSightec:
Exablate
Focused Ultrasound
rGBM
Additional relevant MeSH terms:
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Astrocytoma
Glioblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carboplatin
Antineoplastic Agents