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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042416
• Other study ID #: Pro00055342
• Status: Completed
• Phase: Phase 3
• Start date: June 29, 2017
• Est. completion date: June 2, 2021

Study information

• Verified date: January 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Glioma
• Congenital Hyperinsulinism
• Hyperinsulinism
• Neuroblastoma
• Neuroendocrine Tumors
• Parkinson Disease

Intervention

Drug:
• 18F-DOPA
18F-DOPA intravenous injection single dose

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate safety evaluation	Clinical screen for adverse reactions to 18F-DOPA injection	Within 1 hour of injection
Secondary	Delayed safety evaluation	A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection	10-14 days after injection
Secondary	Delayed safety evaluation - referring physician	Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection	6 months after injection
Secondary	Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected	Scan interpreter will evaluate the distribution of tracer and comment if expected	Within 3 days after injection
Secondary	Perceived clinical benefit	Questionnaire for referring physician to assess perceived clinical benefit of scan	6 months after injection