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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Neuroendocrine Tumors; Neuroblastoma; Congenital Hyperinsulinism; Brain Glioma
• Intervention / Treatment: Drug: 18F-DOPA

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, t6g2b7
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 18F-DOPA scan; 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).	Drug: 18F-DOPA; 18F-DOPA intravenous injection single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate safety evaluation	Clinical screen for adverse reactions to 18F-DOPA injection	Within 1 hour of injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed safety evaluation	A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection	10-14 days after injection
Delayed safety evaluation - referring physician	Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection	6 months after injection
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
Perceived clinical benefit	Questionnaire for referring physician to assess perceived clinical benefit of scan	6 months after injection

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: Jonathan T Abele, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2017
• Primary Completion (ACTUAL): March 5, 2021
• Study Completion (ACTUAL): June 2, 2021

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (ESTIMATE): February 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: 18F-DOPA PET/CT
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Infant, Newborn, Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Hypoglycemia; Parkinson Disease; Hyperinsulinism; Neuroblastoma; Neuroendocrine Tumors; Congenital Hyperinsulinism; Nesidioblastosis
• Other Study ID Numbers: Pro00055342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No