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NCT05317858 · ClinicalTrials.gov record · last posted 2026-08-19

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

Study acronym: LIMITLESS
StatusRecruiting
PhasePhase 3
SponsorInSightec
Started2022-08-12
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 18 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 18 times since 2022-03-31; most recent amendment 2026-07-20. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-09-15
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT05317858
Lead Sponsor InSightec
Conditions Brain Tumor, Non Small Cell Lung Cancer
Enrollment 30 participants
Start Date 2022-08-12
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-19