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Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma

StatusWithdrawn
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Withdrawn before enrolling Sponsor's reason: Other - Protocol moved to Withdrawn Lead sponsor: Children's Oncology Group to Children's Oncology Group · Enrollment target: estimated 84 to confirmed 0 · Eligibility criteria expanded, about 19 words · 2 more Show 5 more changesShow less
    • Lead sponsor: Children's Oncology Group to Children's Oncology Group
    • Enrollment target: estimated 84 to confirmed 0
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Study description revised
  2. Start date: Jun 22, 2026 to Sep 22, 2026v8
  3. Start date: Mar 22, 2026 to Jun 22, 2026 Collaborators shortened, about 4 wordsv7 Show 1 more changeShow less
    • Collaborators shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Dec 22, 2025 to Mar 22, 2026v6
  5. Start date: Sep 22, 2025 to Dec 22, 2025 Collaborators expanded, about 4 wordsv5 Show 1 more changeShow less
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jun 20, 2025 to Sep 22, 2025v4
  2. Re-verified, no change to tracked fieldsv3
  3. Phase: Early Phase 1 to Phase 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial evaluates whether an investigational scan (18F-MFBG positron emission tomography \[PET\]/computed tomography \[CT\] or PET/magnetic resonance imaging \[MRI\]) can accurately detect tumors in patients with newly diagnosed, high-risk neuroblastoma as well as standard of care imaging with 123 I-MIBG. 18F-MFBG is a radioactive diagnostic agent that is injected into a vein and taken up by tumor cells. The cells can then be visualized using PET/CT or PET/MRI scans. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. MRI uses radiofrequency waves and a strong magnetic field rather than x-rays to provide clear and detailed pictures of internal organs and tissues. Combining PET with CT or MRI may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as 18F-MFBG PET/CT or PET/MRI, may detect tumors as well as or better than the current standard imaging with 123 I-MIBG in patients with newly diagnosed, high-risk neuroblastoma.
Trial Details
NCT Number NCT06858501
Lead Sponsor Children's Oncology Group
Conditions Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, High Risk Neuroblastoma
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov