RecruitingPhase 3NCT05317858

Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin


Sponsor

InSightec

Enrollment

30 participants

Start Date

Aug 12, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using focused ultrasound to temporarily open the blood-brain barrier (a protective shield around the brain) can improve how well immunotherapy drugs reach brain metastases from non-small cell lung cancer (NSCLC). The blood-brain barrier normally blocks most cancer drugs from entering the brain. **You may be eligible if...** - You are 18 or older with non-small cell lung cancer (NSCLC) that has spread to the brain - You have been prescribed checkpoint inhibitor immunotherapy as part of your standard care - Your target brain lesion(s) are at least 0.5 cm in size - Your performance status is adequate (Karnofsky ≥70% or ECOG 0–2) **You may NOT be eligible if...** - You have a metallic implant in or near the skull that could interfere with the focused ultrasound device - You have severe blood clotting problems or are on anticoagulants that cannot be safely stopped - You have active serious infection or other conditions that make the procedure unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBlood Brain Barrier Opening - Oncology

BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.

DRUGPembrolizumab

Pembrolizumab infusion

DRUGAtezolizumab

Atezolizumab infusion

DRUGCemiplimab

Cemiplimab infusion

DRUGNivolumab

Nivolumab infusion

DRUGIptilimumab

Iptilimumab infusion


Locations(10)

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

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05317858


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