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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
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 13 to 14v20
  2. Study sites: 11 to 13v19
  3. Study sites: 10 to 11v18
  4. Study sites: 9 to 10v17
  5. Study sites: 8 to 9v16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 7 to 8v15
  2. Study sites: 8 to 7v14
  3. Enrollment target: 20 to 30 Primary completion date: Jun 1, 2024 to Jun 1, 2027 · Completion date: Dec 1, 2024 to Dec 1, 2027 · Interventions: Blood Brain Barrier Disruption - Oncology (Device), Pembrolizumab (Drug) to Atezolizumab (Drug), Blood Brain Barrier Opening - Oncology (Device), Cemiplimab (Drug), Iptilimumab (Drug), Nivolumab (Drug)… · 5 morev13 Show 8 more changesShow less
    • Primary completion date: Jun 1, 2024 to Jun 1, 2027
    • Completion date: Dec 1, 2024 to Dec 1, 2027
    • Interventions: Blood Brain Barrier Disruption - Oncology (Device), Pembrolizumab (Drug) to Atezolizumab (Drug), Blood Brain Barrier Opening - Oncology (Device), Cemiplimab (Drug), Iptilimumab (Drug), Nivolumab (Drug)…
    • Eligibility criteria shortened, about 72 words
    • Secondary endpoints: 3 to 2
    • Study description expanded, about 6 words
    • Site details revised at 6 of 8 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Site contacts updated at 1 of 8 sitesv12
  5. Site contacts updated at 1 of 8 sitesv11
  6. Site contacts updated at 1 of 8 sitesv10
  7. Study sites: 7 to 8v9
  8. Study sites: 6 to 7v8
  9. Study sites: 4 to 6v7
  10. Site contacts updated at 1 of 4 sitesv6
  11. Study sites: 3 to 4 Eligibility criteria shortened, about 51 wordsv5 Show 1 more changeShow less
    • Eligibility criteria shortened, about 51 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 2 to 3v4
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Aug 5, 2022 to Aug 12, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Aug 5, 2022 to Aug 12, 2022
  14. Start date: Jun 1, 2022 to Aug 5, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05317858
Lead Sponsor InSightec
Conditions Brain Tumor, Non Small Cell Lung Cancer
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov