Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorInSightec
About this trial
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 criteria
Qualifiers
Participant is ≥ 18 years of age
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
Disqualifiers
Participant has evidence of acute intracranial hemorrhage
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.
Trial design
Treatments tested in this trial
- Blood Brain Barrier Opening - Oncology
- Pembrolizumab
- Atezolizumab
- Cemiplimab
- Nivolumab
- Iptilimumab
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
11Canada
Sunnybrook Research InstituteM4N 3M5, TorontoOntario, Canada
South Korea
Samsung Medical Center06351, SeoulSeoul, South Korea
United States
Arizona
St. Joseph's Hospital and Medical Center85013, Phoenix United States
California
Hoag Memorial Hospital Presbyterian92663, Newport Beach United States
Sponsors and collaborators
InSightec
Lead sponsor
Source ClinicalTrials.gov