Actively Recruiting
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
Led by InSightec · Updated on 2026-04-16
30
Participants Needed
10
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older
- Participant provides written informed consent for the trial
- Participant agrees to follow all study procedures throughout the study
- Karnofsky Performance Status of 70% or higher and/or ECOG status 0-2
- Diagnosed with non-small cell lung cancer and prescribed immune checkpoint inhibitor therapy on-label
- Has brain metastases measuring at least 0.5 cm in longest diameter, including untreated or previously treated lesions
- Female participants are not pregnant and do not plan to become pregnant during the study
- Screening and baseline labs meet local standard of care for immune checkpoint inhibitor therapy
You will not qualify if you...
- Evidence of acute intracranial hemorrhage
- Risk factors for spontaneous brain bleeding, such as history of metastatic melanoma
- Symptoms of increased intracranial pressure or brain herniation
- Receiving Bevacizumab or other drugs that increase bleeding risk
- History of bleeding disorders or conditions increasing bleeding risk
- Active infections including viral (Hepatitis B, C, HIV) or bacterial (TB) infections
- Evidence of cranial or systemic infection
- History of solid organ or stem cell transplant
- Receipt of live vaccine within 28 days before first study treatment
- Known allergy or sensitivity to DEFINITY ultrasound contrast or related substances
- Contraindications to MRI, including incompatible devices or severe claustrophobia
- Significant liver disease or active hepatitis
- Immunodeficiency or recent high-dose steroid or immunosuppressive therapy
- Additional active cancer requiring treatment
- Known leptomeningeal disease
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Any condition or therapy that could interfere with study results or participation
- Current enrollment in another intervention-based clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Not Yet Recruiting
2
Miami Cancer Institute at Baptist Health
Miami, Florida, United States, 33176
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
6
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
8
Johnston Willis Hospital
Richmond, Virginia, United States, 23235
Actively Recruiting
9
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Completed
10
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Not Yet Recruiting
Research Team
A
Alyssa Voelker-Christy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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