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Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors

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: NCT05383872
Recruitment Status : Recruiting
First Posted : May 20, 2022
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors

Condition or disease Intervention/treatment Phase
Glioblastoma Glioma Liquid Biopsy Device: Focused Ultrasound (Exablate Model 4000) Not Applicable

Detailed Description:
This is a prospective, multi-center, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for liquid biopsy in subjects with suspected Glioblastoma brain tumors. The study will be conducted at up to 25 centers in the US.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
Actual Study Start Date : August 8, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Brain Tumors

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exablate BBBD
Using Exablate Model 4000 Type 2 for liquid biopsy in subjects with Glioblastoma
 Device: Focused Ultrasound (Exablate Model 4000)
BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Through study completion, up to 1 year ]
    All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE

  2. Correlation with Tumor Tissue [ Time Frame: Up to 3 hours Post-BBBD ]
    To demonstrate there is a correlation between patterns obtained in the panel of biomarkers evaluated in the resected tumor tissue and/or biopsy and blood sample collected post-BBBD


Secondary Outcome Measures :
  1. Circulating Free DNA [ Time Frame: Up to 3 hours Post-BBBD ]
    To demonstrate that there is at least a 2-fold increase in circulating free DNA following blood brain barrier disruption (BBBD)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Male or Female subjects18-80 years of age who are able and willing to give informed consent, or whose legally authorized representative is willing to consent on their behalf
  2. Subjects with stereotactically-targetable suspected new or recurrent glioblastoma tumor on pre-operative brain imaging scans
  3. Subjects that are scheduled, or will be scheduled within 4 weeks, for surgical resection or biopsy per standard clinical tumor care
  4. Karnofsky Performance Score >70
  5. Able to communicate sensations during the Exablate BBBD procedure

Exclusion Criteria:

  1. Subjects with inoperable tumors (e.g., tumor originating from the deep midline, thalamus, midbrain, cerebellum or brainstem)
  2. Multifocal tumors
  3. Tumor morphology or other imaging findings that precludes the ability to sonicate the tumor volume (including significant tumor volume outside the treatment envelope or tumor volume that exceeds the maximum sonication volume allowed, i.e. currently 110 ccs at the treatment volume level). Concern for adequate tumor coverage by sonication based on tumor morphology should be discussed with the Sponsor.

  4. MRI or clinical findings of:

    1. Active or chronic infection(s) or inflammatory processes
    2. Acute or chronic hemorrhages, specifically any lobar microbleeds, and no siderosis, amyloid angiopathy, or macro-hemorrhages
    3. Intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis
  5. MR non-compatible metallic implants in the skull or the brain or the presence of unknown MR unsafe devices

  6. Significant cardiac disease or unstable hemodynamic status

    1. Documented myocardial infarction within six months of enrollment
    2. Unstable angina on medication
    3. Unstable or worsening congestive heart failure
    4. Documented left ventricular ejection fraction below the lower limit of normal
    5. History of a hemodynamically unstable cardiac arrhythmia
    6. Cardiac pacemaker
  7. Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication)
  8. Undergoing anti-coagulant or anti-platelet therapy, or using medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).
  9. History of bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or evidence of increased risk of bleeding
  10. Abnormal coagulation profile (Platelets < 80,000, PT >14, PTT >36, or INR > 1.3)
  11. Known cerebral or systemic vasculopathy
  12. Significant depression and at potential risk of suicide
  13. Known sensitivity/allergy to gadolinium or DEFINITY/DEFINITY RT,
  14. Active seizures despite medication treatment (defined as >1 seizure per week) which could be worsened by disruption of the blood brain barrier
  15. Active drug or alcohol disorder which have a higher risk for seizures, infection and/or poor executive functioning
  16. Known positive HIV status, which can lead to increased entry of HIV into the brain parenchyma leading to HIV encephalitis
  17. Potential blood-borne infections which can lead to increased entry to brain parenchyma leading to meningitis or brain abscess

  18. Any contraindications to MRI scanning, including:

    1. Large subjects not fitting comfortably into the scanner
    2. Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia
  19. Impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
  20. Severe Respiratory Illness: chronic pulmonary disorders (e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area), subjects with a history of severe drug allergies, severe asthma or hay fever, or multiple allergies where the benefit/risk of administering DEFINITY/DEFINITY RT is considered unfavorable by the study physicians in relation to the product labeling for DEFINITY/DEFINITY RT
  21. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device
  22. Pregnancy or Lactation
Contacts and Locations
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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): NCT05383872


Contacts
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Contact: Julia Zhu 1-214-846-2577 juliaz@insightec.com
Contact: Matt Hibert matthewh@insightec.com

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Karolin Markarian    424-832-6099    kmarkarian@mednet.ucla.edu   
Principal Investigator: Richard Everson, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94107
Contact: Stephanie Lewis    415-353-2193    NeuroOncNewPatientCoord@ucsf.edu   
Principal Investigator: John de Groot, M.D.         
United States, Florida
UF Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32608
Contact: Phuong Deleyrolle, RN    352-273-5529    pdeleyrolle@ufl.edu   
Principal Investigator: Justin Hilliard, MD         
Miami Cancer Institute at Baptist Health Recruiting
Miami, Florida, United States, 33176
Contact: Daylen Santana    786-595-4628    daylens@BaptistHealth.net   
Principal Investigator: Manmeet Ahluwalia         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Kathryn Hudson    813-844-4113    khudson@tgh.org   
Principal Investigator: Yarema Bezchlibnyk, MD         
United States, Maryland
University of Maryland, Baltimore & The University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kaitlyn Henry    410-328-0939    khenry@som.umaryland.edu   
Principal Investigator: Graeme Woodworth, MD         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Jessica Wollet    667-306-8141    jwollet1@jh.edu   
Principal Investigator: Jordina Rincon Torroella         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Adam Loudermilk    507-422-0718    loudermilk.adam@mayo.edu   
Principal Investigator: Terence Burns, MD, PhD         
United States, New York
NYU Grossman School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Cathryn Lapierre    646-501-2762    cathryn.lapierre@nyulangone.org   
Contact: Shannon Ciprut    212-263-4076    shannon.ciprut@nyulangone.org   
Principal Investigator: Alon Mogilner         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Stevie Threatt    919-684-5301    dukebrain1@dm.duke.edu   
Principal Investigator: Gerald Grant, MD         
United States, Pennsylvania
University of Pennsylvania Withdrawn
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas, Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Vida Rhodes    214-648-5474    Vida.Rhodes@UTSouthwestern.edu   
Principal Investigator: Bhavya Shah, MD         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sharon Ji    713-563-8711    xji@mdanderson.org   
Principal Investigator: Jeffrey Weinberg, MD         
United States, West Virginia
West Virginia University Rockefeller Neuroscience Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Kiley Everson, RN, BSN    304-293-9146    kiley.everson@hsc.wvu.edu   
Principal Investigator: Christopher Cifarelli, MD, PhD         
Canada, Ontario
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Maheleth Llinas    416-480-6100 ext 2476    maheleth.llinas@sunnybrook.ca   
Principal Investigator: Nir Lipsman         
Sponsors and Collaborators
InSightec
More Information
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT05383872    
Other Study ID Numbers: BT015
First Posted: May 20, 2022    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue