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18F-DOPA II - PET Imaging Optimization

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2027
    • Study completion date: Jul 2026 to Dec 2027
    v7
  2. 4 versions Re-verified since Apr 11, 2022, no change to tracked fieldsv3-v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2021 to Jan 20, 2021
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2. Pediatric patients (less than 18 years old) with neuroblastoma. 3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor. 4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia. 5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors. Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.
Trial Details
NCT Number NCT04706910
Lead Sponsor University of Alberta
Conditions
(from sponsor)		 Congenital Hyperinsulinism, Neuroblastoma, Parkinson Disease, Lewy Body Disease, Neuroendocrine Tumors, Brain Tumor
Related terms Brain Neoplasms, Congenital Hyperinsulinism, Lewy Body Disease, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov