Clinical trialNCT05317858RecruitingPhase 3Interventional

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

SponsorInSightecEnrollment30Brain TumorNon Small Cell Lung Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Manmeet Ahluwalia, MD, MBA
Miami Cancer Institute, Baptist Health South Florida
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Sunnybrook Research Institute
Toronto, Ontario, Canada
Active, not recruiting

South Korea

Samsung Medical Center
Seoul, Seoul, South Korea
Kyung-won Chang
Not, yet, recruiting
Seoul National University Hospital
Seoul, South Korea
Eun-jung Lee
Not, yet, recruiting
Severance Hospital, Yonsei University Health System
Soeul, South Korea
Hyun Ho Jung
Not, yet, recruiting

United States

St. Joseph'S Hospital and Medical Center
Phoenix, Arizona, United States
Withdrawn
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Recruiting
Broward Health
Fort Lauderdale, Florida, United States
Mehmet Hepgur, MDShaye Moskowitz, MD
Recruiting
Miami Cancer Institute at Baptist Health
Miami, Florida, United States
Manmeet S Ahluwalia, MD
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Yolanda Pina, Neuro-Oncology
Recruiting
University of Maryland
Baltimore, Maryland, United States
Alexander Ksendzovsky, MDGraeme Woodworth, MDHoward Eisenberg, MD
Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Adrian Laxton, BA, MA, MD, FRCSC, FAANS
Recruiting
Oregon Health & Science University
Portland, Oregon, United States
Ahmed Raslan, MBBCh, MSc, MD, FAANS
Recruiting
Rhode Island Hospital
Providence, Rhode Island, United States
Clark Chen
Recruiting
Johnston Willis Hospital
Richmond, Virginia, United States
Active, not recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Atezolizumab →Cemiplimab →IptilimumabNivolumab →Pembrolizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 12 Aug 2022
Primary completion: 1 Jun 2027
Completion: 1 Dec 2027
Last update posted: 19 Aug 2026
Registered enrollment: 30
Registry id: NCT05317858

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.