Clinical trial · Interventional
18F-DOPA II - PET Imaging Optimization
- 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)
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.
Conditions
Conditions (6)
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 Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Congenital Hyperinsulinism | — | UNRESOLVED | — |
| Lewy Body Disease | — | UNRESOLVED | — |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Parkinson Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DOPA | Drug | — | UNRESOLVED |
| Furosemide Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DOPA injection
- description
- All enrolled participants will receive an intravenous injection of the investigational 18F-DOPA radiopharmaceutical
- interventionNames
- Drug: 18F-DOPA
- Drug: Furosemide Injection
Primary outcomes (4)
- measure
- Minimum lesion detectibility (size)
- timeFrame
- Within 1 month of PET/CT scan
- description
- Measurement of size (mm) of the three smallest lesions
- measure
- Assessment of bladder activity
- timeFrame
- Within 1 month of PET/CT scan
- description
- Measurement of standardized uptake value (SUV) for urinary bladder activity
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 1. Unable to obtain consent 2. Weight \>225 kg (weight limitation of PET/CT scanner) 3. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session. 4. Young pediatric patients (less than 13 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). 5. Lack of intravenous access 6. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only) 7. Pregnancy
References
Publications (0)
Data not yet available