Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
NCT ID: NCT05317858
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
30 participants
INTERVENTIONAL
2022-08-12
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICI Systemic Therapy with Exablate BBBO
Using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned ICI Systemic Therapy.
Blood Brain Barrier Opening - Oncology
BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
Pembrolizumab
Pembrolizumab infusion
Atezolizumab
Atezolizumab infusion
Cemiplimab
Cemiplimab infusion
Nivolumab
Nivolumab infusion
Iptilimumab
Iptilimumab infusion
Control Arm (ICI Systemic Therapy on-label use only)
subjects will undergo planned on-label ICI Systemic Therapy.
Pembrolizumab
Pembrolizumab infusion
Atezolizumab
Atezolizumab infusion
Cemiplimab
Cemiplimab infusion
Nivolumab
Nivolumab infusion
Iptilimumab
Iptilimumab infusion
Interventions
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Blood Brain Barrier Opening - Oncology
BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
Pembrolizumab
Pembrolizumab infusion
Atezolizumab
Atezolizumab infusion
Cemiplimab
Cemiplimab infusion
Nivolumab
Nivolumab infusion
Iptilimumab
Iptilimumab infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The participant provides written informed consent for the trial
* Participant is willing to comply with all study procedures for the duration of the study
* Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2
* Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and/or if in the opinion of the Investigator, the subject may benefit from the study procedure.
* Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day.
* Screening/Baseline laboratory values Screening/Baseline should adhere to local standard of care lab values for ICI therapy
Exclusion Criteria
* Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).
* Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.
* Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.
* History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.
* Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the opinion of the investigator, interfere with the subject receiving the study therapy or procedures or otherwise impact their participation in the trial.
* Subjects with evidence of cranial or systemic infection.
* Participant has received a solid organ or hematopoietic stem cell transplant.
* Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate.
* Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products.
* Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI.
* Subjects with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious))
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first on-study ICI infusion with or without Exablate. Note: prophylactic steroid use for ICI and chemotherapy infusion per institutional practice is allowed per protocol.
* Has a known additional malignancy that requires active treatment that would interfere with study procedures.
* Known presence of leptomeningeal disease.
* Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Subject is currently enrolled in another intervention based clinical trial
18 Years
100 Years
ALL
No
Sponsors
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InSightec
INDUSTRY
Responsible Party
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Principal Investigators
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Manmeet Ahluwalia, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Miami Cancer Institute, Baptist Health South Florida
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Miami Cancer Institute at Baptist Health
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Maryland
Baltimore, Maryland, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Johnston Willis Hospital
Richmond, Virginia, United States
Sunnybrook Research Institute
Toronto, Ontario, Canada
Samsung Medical Center
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BT012
Identifier Type: -
Identifier Source: org_study_id
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