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

University of Alberta

Status and phase: Completed; Phase 3

Conditions: Neuroblastoma; Brain Glioma; Parkinson Disease; Neuroendocrine Tumors; Congenital Hyperinsulinism

Treatments: Drug: 18F-DOPA

Study type: Interventional

Funder types: Other

Identifiers

NCT03042416

Pro00055342

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

18F-DOPA scan

Experimental group

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).

Treatment:

Drug: 18F-DOPA