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

NCT05317858 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-16

No results posted yet for this study

Summary

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

Interventions

DEVICE

Blood Brain Barrier Opening - Oncology

BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.

DRUG

Pembrolizumab

Pembrolizumab infusion

DRUG

Atezolizumab

Atezolizumab infusion

DRUG

Cemiplimab

Cemiplimab infusion

DRUG

Nivolumab

Nivolumab infusion

DRUG

Iptilimumab

Iptilimumab infusion

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Manmeet Ahluwalia, MD, MBA · Miami Cancer Institute, Baptist Health South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2027-06-01
Completion
2027-12-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317858 on ClinicalTrials.gov