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

Phase 3

Completed

• Conditions: Neuroblastoma; Neuroendocrine Tumors; Parkinson Disease; Congenital Hyperinsulinism; Brain Glioma
• Interventions: Drug: 18F-DOPA

• Registration Number: NCT03042416
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2017-06-29
• Primary Completion: 2021-03-05
• Study Completion: 2021-06-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DOPA scan	18F-DOPA	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).

Primary Outcome Measures

Name	Time	Method
Immediate safety evaluation	Within 1 hour of injection	Clinical screen for adverse reactions to 18F-DOPA injection

Secondary Outcome Measures

Name	Time	Method
Delayed safety evaluation - referring physician	6 months after injection	Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection
Delayed safety evaluation	10-14 days after injection	A telephone survey to evaluate for delayed 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

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada