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Open-Label Study of 18F-mFBG for Imaging Neuroblastoma

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 2 entries
  2. Trial completed Eligibility criteria expanded, about 8 words · Site details revised at 3 of 8 sites Show 2 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 3 of 8 sites
  3. Re-verified, no change to tracked fieldsv16
  4. Primary completion date: May 1, 2024 to Jul 30, 2026 Trial status: Completed to Active, Not Recruiting · Completion date: May 1, 2024 to Aug 30, 2026v15 Show 2 more changesShow less
    • Trial status: Completed to Active, Not Recruiting
    • Completion date: May 1, 2024 to Aug 30, 2026
  5. Primary and study completion dates: Feb 1, 2024 to May 1, 2024v14
Show 12 earlier versionsHide 12 earlier versions
  1. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of May 1, 2024 to Feb 1, 2024v13 Show 1 more changeShow less
    • Study completion date changed from estimate of May 1, 2024 to Feb 1, 2024
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 50 to confirmed 43 · Primary completion date changed from estimate of Jan 2024 to Feb 1, 2024 · Completion date: Jan 2024 to May 1, 2024 · 1 morev12 Show 4 more changesShow less
    • Enrollment target: estimated 50 to confirmed 43
    • Primary completion date changed from estimate of Jan 2024 to Feb 1, 2024
    • Completion date: Jan 2024 to May 1, 2024
    • Site details revised at 8 of 8 sites
  3. Primary completion date: Nov 2022 to Jan 2024 Start date: Sep 24, 2021 to Nov 18, 2021 · Completion date: Dec 2022 to Jan 2024v11 Show 2 more changesShow less
    • Start date: Sep 24, 2021 to Nov 18, 2021
    • Completion date: Dec 2022 to Jan 2024
  4. Study sites: 7 to 8 Primary completion date: Sep 2022 to Nov 2022v10 Show 1 more changeShow less
    • Primary completion date: Sep 2022 to Nov 2022
  5. Study sites: 6 to 7v9
  6. Study sites: 5 to 6v8
  7. Study sites: 4 to 5v7
  8. Study sites: 3 to 4v6
  9. Study sites: 1 to 3v5
  10. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 2021 to Sep 2022 · Study sites: 0 to 1 · Completion date: Mar 2022 to Dec 2022 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Dec 2021 to Sep 2022
    • Study sites: 0 to 1
    • Completion date: Mar 2022 to Dec 2022
    • Start date changed from estimate of Sep 2021 to Sep 24, 2021
  11. Start date: Apr 2021 to Sep 2021v3
  12. Collaborators: 1 to 2v2 See this version in full on ClinicalTrials.gov ↗
  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.
This is a Phase 3 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for confirming or excluding the presence of neuroblastoma
Trial Details
NCT Number NCT04724369
Lead Sponsor Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Collaborators: New Approaches to Neuroblastoma Therapy Consortium, Memorial Sloan Kettering Cancer Center
Conditions Neuroblastoma
Enrollment 43 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov