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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440358
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE June 17, 2020
First Posted Date  ICMJE June 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE October 13, 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Occurrence of 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • 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
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
Official Title  ICMJE 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
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.
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. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE
  • Device: Exablate BBBD
    BBB opening via Exablate Neuro Type 2 system to deliver carboplatin
    Other Name: Exablate Neuro
  • Drug: Carboplatin
    Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
Study Arms  ICMJE 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.
Interventions:
  • Device: Exablate BBBD
  • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)		 40
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2020)		 10
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/assent
  • Tumor progression after first line therapy
  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julia Zhu 972 421 0480 juliaz@insightec.com
Contact: Patrice Horwath patriceh@insightec.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04440358
Other Study ID Numbers  ICMJE BT009 [OUS]
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InSightec
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP