18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborator: Alberta Health Services
• Treatments: Dihydroxyphenylalanine

Criteria

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