Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma
Conditions
Keywords
18F-DOPA PET/CT
Brief summary
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.
Interventions
DRUG18F-DOPA
18F-DOPA intravenous injection single dose
Sponsors
Alberta Health services
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate safety evaluation | Within 1 hour of injection | Clinical screen for adverse reactions to 18F-DOPA injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed safety evaluation | 10-14 days after injection | A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection |
| Delayed safety evaluation - referring physician | 6 months after injection | Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection |
| Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected | Within 3 days after injection | Scan interpreter will evaluate the distribution of tracer and comment if expected |
| Perceived clinical benefit | 6 months after injection | Questionnaire for referring physician to assess perceived clinical benefit of scan |
Countries
Canada
Outcome results
None listed