Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
Public ClinicalTrials.gov record NCT05317858. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05317858
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 96 participants
Conditions and interventions
Conditions
Interventions
- Blood Brain Barrier Opening - Oncology Device
- Pembrolizumab Drug
- Atezolizumab Drug
- Cemiplimab Drug
- Nivolumab Drug
- Iptilimumab Drug
Device · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2022 (Actual)
- Primary completion
- Jun 1, 2031 (Estimated)
- Completion
- Dec 1, 2031 (Estimated)
- Last update posted
- Oct 13, 2026
2022 – 2031
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | Withdrawn |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | Recruiting |
| Broward Health | Fort Lauderdale | Florida | 33316 | Recruiting |
| Miami Cancer Institute at Baptist Health | Miami | Florida | 33176 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| University of Maryland | Baltimore | Maryland | 21201 | Recruiting |
| Duke University | Durham | North Carolina | 27708 | Recruiting |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27103 | Recruiting |
| Oregon Health & Science University | Portland | Oregon | 97239 | Recruiting |
| UPMC Presbyterian Hospital - University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | Not yet recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| Johnston Willis Hospital | Richmond | Virginia | 23235 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05317858, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05317858 live on ClinicalTrials.gov.