Clinical trial · Interventional
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor 4. Adult patients with a clinical suspicion of Parkinson's disease 5. Pediatric or Adult patients with primary brain tumors This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Glioma | — | UNRESOLVED | — |
| Congenital Hyperinsulinism | — | UNRESOLVED | — |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Parkinson Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DOPA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DOPA scan
- description
- 18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient).
- interventionNames
- Drug: 18F-DOPA
Primary outcomes (1)
- measure
- Immediate safety evaluation
- timeFrame
- Within 1 hour of injection
- description
- Clinical screen for adverse reactions to 18F-DOPA injection
Secondary outcomes (4)
- measure
- Delayed safety evaluation
- timeFrame
- 10-14 days after injection
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 1\. Pediatric patients (less than 17 years old) with congenital hyperinsulinism * 2\. Pediatric patients (less than 17 years old) with neuroblastoma * 3\. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas * 4\. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease. * 5\. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors Exclusion Criteria: * Unable to obtain consent * Weight \> 250 kg (weight limitation of PET/CT scanner) * Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan * Young pediatric patients (less than 10 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist) * Pregnancy * Lack of intravenous access
References
Publications (0)
Data not yet available