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Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from Children's Hospital of Philadelphia

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2027 Show 5 more changesShow less
    • Lead sponsor: Children's Hospital of Philadelphia to Children's Hospital of Philadelphia
    • Start date: Jul 29, 2026 to Nov 29, 2026
    • Study completion pushed from Sep 2027 to Sep 2028
    • Eligibility criteria expanded, about 12 words
    • Publications: details revised at 26 of 27 entries
  2. Start date: Dec 29, 2025 to Jul 29, 2026
    • Primary completion date: Sep 2026 to Dec 2026
    v12
  3. Start date: Apr 29, 2025 to Dec 29, 2025
    • Eligibility criteria shortened, about 4 words
    v11
  4. Primary completion date: Sep 2025 to Sep 2026
    • Study completion date: Sep 2026 to Sep 2027
    • Start date changed from estimate of Mar 3, 2025 to Apr 29, 2025
    v10
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2024 to Mar 3, 2025
    • Eligibility criteria expanded, about 7 words
    • Study site revised
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Start date: Jan 2024 to Jul 2024v7
  3. Start date: Sep 2023 to Jan 2024
    • Eligibility criteria expanded, about 8 words
    v6
  4. Start date: Jul 2023 to Sep 2023v5
  5. Start date: Apr 2023 to Jul 2023v4
  6. Start date: Oct 2022 to Apr 2023v3
  7. Start date: Sep 2022 to Oct 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.
Trial Details
NCT Number NCT05555550
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: Blue Earth Diagnostics, Dragon Master Foundation
Conditions
(from sponsor)		 Glioma, Low-grade Glioma, Low Grade Glioma of Brain, Glioma, Malignant, Glioma Intracranial
Related terms Glioma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov