Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets (NCT05317858)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Joseph's Hospital and Medical Center — Phoenix, Arizona
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Broward Health — Fort Lauderdale, Florida
- Miami Cancer Institute at Baptist Health — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- University of Maryland — Baltimore, Maryland
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina
- Oregon Health & Science University — Portland, Oregon
- Rhode Island Hospital — Providence, Rhode Island
- Johnston Willis Hospital — Richmond, Virginia
- Sunnybrook Research Institute — Toronto, Ontario
- Samsung Medical Center — Seoul, Seoul
- Seoul National University Hospital — Seoul,
- Severance Hospital, Yonsei University Health System — Soeul,
📞 Contact the Study Coordinator
Phone: (817) 948-5219
Email: clinicalresearchquestions@insightec.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Brain Tumor
- Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound — Toronto, Ontario
- Quantitative Assessment of Radiation-induced Neuroinflammation - A Proof of Principle Study — Memphis, Tennessee
- Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors — Hartford, Connecticut
- Understanding the Late Effects of Surviving a Pediatric Brain Tumor — New York, New York
- Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG — Toronto, Ontario
- Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors. — Miami, Florida
Explore by condition: All Brain Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.