drugset / Trial / NCT04706910

18F-DOPA II - PET Imaging Optimization

NCT04706910

Phase 3 Recruiting 800 enrolled University of Alberta
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2021-01-20
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-DOPA Diagnostic / imaging agent 4 mbq/kg Intravenous
Subject Furosemide Other / unclassified 40 mg Intravenous