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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
InSightec
Study ID
NCT05317858
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Blood Brain Barrier Opening - Oncology — DEVICE
    BBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
  • Pembrolizumab — DRUG
    Pembrolizumab infusion
  • Atezolizumab — DRUG
    Atezolizumab infusion
  • Cemiplimab — DRUG
    Cemiplimab infusion
  • Nivolumab — DRUG
    Nivolumab infusion
  • Iptilimumab — DRUG
    Iptilimumab infusion

Study Details

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.

Key Dates

Start date
Aug 12, 2022
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ICI Systemic Therapy with Exablate BBBO
    Using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned ICI Systemic Therapy.
  • Active Comparator: Control Arm (ICI Systemic Therapy on-label use only)
    subjects will undergo planned on-label ICI Systemic Therapy.

Primary Outcome Measure

Adverse events [ Time Frame: up to 6 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Jamie Sanders
[email protected]
602-406-8605
Nader Sanai, MD (PRINCIPAL_INVESTIGATOR)
Miami Cancer Institute at Baptist HealthMiamiFlorida33176
Kevin Vazquez
[email protected]
786-594-7641
Manmeet S Ahluwalia, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Carie Bliss
[email protected]
(813) 745-2131
Yolanda Pina, Neuro-Oncology (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Kaitlyn Henry
[email protected]
410-328-0939
Rayne Noyes
[email protected]
410-328-5332
Graeme Woodworth, MD (PRINCIPAL_INVESTIGATOR)
Howard Eisenberg, MD (SUB_INVESTIGATOR)
Alexander Ksendzovsky, MD (SUB_INVESTIGATOR)
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27103
Adrian Laxton, BA, MA, MD, FRCSC, FAANS
[email protected]
336-716-6438
Wendy Jenkins, RN, BSN
[email protected]
336-716-3842
Adrian Laxton, BA, MA, MD, FRCSC, FAANS (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Michael McGehee, MS
[email protected]
971-509-4932
Ahmed Raslan, MBBCh, MSc, MD, FAANS (PRINCIPAL_INVESTIGATOR)
Rhode Island HospitalProvidenceRhode Island02903
Maria Duffy
[email protected]
(401) 444-2243
Owen Leary
[email protected]
(401) 606-8388
Clark Chen (PRINCIPAL_INVESTIGATOR)
Johnston Willis HospitalRichmondVirginia23235
Kanwalcharan S Sahni, MD
[email protected]
804-330-4990
Kanwalcharan Sahni, Neurosurgery (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Brain cancerLung cancer
By specialty
OncologyNeuro-oncologyLung oncologyLung disease
By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZMiami Cancer Institute at Baptist Health· Miami, FLMoffitt Cancer Center· Tampa, FLUniversity of Maryland· Baltimore, MDAtrium Health Wake Forest Baptist· Winston-Salem, NCOregon Health & Science University· Portland, OR

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