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18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

Study acronym: DOPA PET
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 1, 2026v6
  2. Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study completion date: Dec 31, 2026 to Dec 31, 2025
    v5
  3. Study completion date: Dec 31, 2023 to Dec 31, 2026v4
  4. Re-verified, no change to tracked fieldsv3
  5. Phase: Phase 1 to Phase 2v2 Show 4 more changesShow less
    • Lead sponsor: University of California, San Francisco to Miguel Pampaloni
    • Primary and study completion dates: Dec 31, 2021 to Dec 31, 2023
    • Interventions: 18F-Fluoro Dopa Imaging (Diagnostic Test) to 18F-Fluoro Dopa Imaging (Drug)
    • Eligibility criteria revised
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.
Trial Details
NCT Number NCT04205604
Lead Sponsor Miguel Pampaloni
Conditions
(from sponsor)		 Congenital Hyperinsulinism
Related terms Congenital Hyperinsulinism
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov