COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-08-08

Study Completion:2025-03-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05383872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92618

United States

University of California San Francisco

San Francisco, California, 94107

United States

UF Health Shands Hospital

Gainesville, Florida, 32608

United States

Miami Cancer Institute at Baptist Health

Miami, Florida, 33176

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

University of Maryland, Baltimore & The University of Maryland Medical System

Baltimore, Maryland, 21201

United States

Johns Hopkins University

Baltimore, Maryland, 21218

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

NYU Grossman School of Medicine

New York, New York, 10016

United States

University of North Carolina

Chapel Hill, North Carolina, 27516

United States

Duke University

Durham, North Carolina, 27710

United States

University of Texas, Southwestern

Dallas, Texas, 75390

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

West Virginia University Rockefeller Neuroscience Center

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: InSightec

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-08

Study Completion Date2025-03-05

Study Record Updates

Study Start Date2022-08-08

Study Completion Date2025-03-05

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma
Glioma
Liquid Biopsy