Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective Exablate focused ultrasound is at opening the barrier between the blood and brain in a targeted area. It is for adults with non-small cell lung cancer (NSCLC) that has spread to the brain who are getting approved immune checkpoint drugs, which help the immune system fight cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are at least 18 years old.
- You sign a consent form and agree to follow all study steps.
- You meet the study’s scores for being able to care for yourself and do daily tasks.
- You have NSCLC that has spread to the brain and are prescribed an immune checkpoint drug for an approved use.
- The brain tumor being treated is at least 0.5 cm across. It must meet study rules about surgery, past radiation, and timing.
- If you are female, you do not plan to become pregnant during the study and test negative for pregnancy on each procedure day.
- Your blood test results meet local standards for immune checkpoint treatment.
Who can't join
- You have new bleeding in the brain, a high bleeding risk, a bleeding disorder, or take Avastin or other drugs likely to cause bleeding.
- You have signs of high pressure in the skull, brain swelling or shifting that causes symptoms, or cancer in the lining around the brain and spinal cord.
- You have an infection in the head or body, or certain active infections such as hepatitis B or C, HIV with a detectable virus level, or tuberculosis that may affect study care.
- You have had an organ or blood-forming stem cell transplant, or a live vaccine within 28 days before the first study immune checkpoint treatment.
- You are allergic to DEFINITY ultrasound dye or its ingredients, or cannot safely have an MRI or its dye. This includes certain implants, severe fear of tight spaces, or being unable to lie on your back.
- You have serious liver problems, a weak immune system, or recent treatment that lowers immune activity. This includes ongoing steroids above 10 mg of prednisone daily or an equal dose; some preventive steroids are allowed.
- You have an autoimmune disease, where the body attacks itself, that needed whole-body treatment in the past 2 years, except hormone replacement. You have lung inflammation now or had noninfectious lung inflammation that needed steroids.
- You have another cancer needing treatment that would affect the study, are in another trial testing a treatment, or have another condition, treatment, or test result that the doctor thinks makes this study unsuitable.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Participant is ≥ 18 years of age * The participant provides written informed consent for the trial * Participant is willing to comply with all study procedures for the duration of the study * Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2 * Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and/or if in the opinion of the Investigator, the subject may benefit from the study procedure. * Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day. * Screening/Baseline laboratory values Screening/Baseline should adhere to local standard of care lab values for ICI therapy Exclusion Criteria * Participant has evidence of acute intracranial hemorrhage * Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology). * Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation. * Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding. * History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event. * Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the opinion of the investigator, interfere with the subject receiving the study therapy or procedures or otherwise impact their participation in the trial. * Subjects with evidence of cranial or systemic infection. * Participant has received a solid organ or hematopoietic stem cell transplant. * Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate. * Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products. * Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI. * Subjects with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious)) * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first on-study ICI infusion with or without Exablate. Note: prophylactic steroid use for ICI and chemotherapy infusion per institutional practice is allowed per protocol. * Has a known additional malignancy that requires active treatment that would interfere with study procedures. * Known presence of leptomeningeal disease. * Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Subject is currently enrolled in another intervention based clinical trial
Study sites (12)
AZ
- St. Joseph's Hospital and Medical Center · Phoenix, AZ 85013More trials in Phoenix
CA
- Hoag Memorial Hospital Presbyterian · Newport Beach, CA 92663Simon Khagi, MD, MBA, FACP · Study contact · 949-764-4060 · Simon.Khagi@hoag.orgJulie Nguyen · Study contact · (949) 764-6271 · Julie.Nguyen@hoag.orgMore trials in Newport Beach
FL
- Broward Health · Fort Lauderdale, FL 33316Shirley Cheraime, RN, BSN · Study contact · 954.712.3904 · scheraime@browardhealth.orgSimone Dockery Franklin · Study contact · Sfranklin@browardhealth.orgShaye Moskowitz, MD · Principal investigatorMehmet Hepgur, MD · Sub-investigatorMore trials in Fort Lauderdale
- Miami Cancer Institute at Baptist Health · Miami, FL 33176Natalie Brunelle · Study contact · 786-533-9460 · Natalie.Brunelle@Baptisthealth.netManmeet S Ahluwalia, MD · Principal investigatorMore trials in Miami
- Moffitt Cancer Center · Tampa, FL 33612Carie Bliss · Study contact · (813) 745-2131 · Carie.Bliss@moffitt.orgYolanda Pina, Neuro-Oncology · Principal investigatorMore trials in Tampa
MD
- University of Maryland · Baltimore, MD 21201Kaitlyn Henry · Study contact · 410-328-0939 · KHenry@som.umaryland.eduRayne Noyes · Study contact · 410-328-5332 · anoyes@som.umaryland.eduGraeme Woodworth, MD · Principal investigatorHoward Eisenberg, MD · Sub-investigatorMore trials in Baltimore
NC
- Duke University · Durham, NC 27708Julia Hurrelbrink - Assistant Research Practice Manager, BA, BSN, RN · Study contact · (919)681-7460 · julia.hurrelbrink@duke.eduLaura Alder, Medical Oncology, Internal Med · Principal investigatorGerald Grant, Neurological Surgery · Sub-investigatorMore trials in Durham
- Atrium Health Wake Forest Baptist · Winston-Salem, NC 27103Adrian Laxton, BA, MA, MD, FRCSC, FAANS · Study contact · 336-716-6438 · Adrian.Laxton@wfusm.eduWendy Jenkins, RN, BSN · Study contact · 336-716-3842 · Wendy.Jenkins@Advocatehealth.orgAdrian Laxton, BA, MA, MD, FRCSC, FAANS · Principal investigatorMore trials in Winston-Salem
OR
- Oregon Health & Science University · Portland, OR 97239Michael McGehee, MS · Study contact · 971-509-4932 · nsgclinicalresearch@ohsu.eduAhmed Raslan, MBBCh, MSc, MD, FAANS · Principal investigatorMore trials in Portland
PA
- UPMC Presbyterian Hospital - University of Pittsburgh · Pittsburgh, PA 15213Kristy Boggs, PhD · Study contact · 412-647-8952 · boggskd@upmc.eduConstantinos Hadjipanayis, Neurosurgery · Principal investigatorAjay Niranjan, Neurosurgery · Sub-investigatorJan Drappatz, Neuro-oncology · Sub-investigatorMore trials in Pittsburgh
RI
- Rhode Island Hospital · Providence, RI 02903Maria Duffy · Study contact · (401) 444-2243 · mduffy@brownhealth.orgOwen Leary · Study contact · (401) 606-8388 · owen.leary@brownhealth.orgClark Chen · Principal investigatorMore trials in Providence
VA
- Johnston Willis Hospital · Richmond, VA 23235More trials in Richmond