18F-DOPA PET Imaging: An Evaluation Of Biodistribution And Safety

Study Overview

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.

N/A

Congenital Hyperinsulinism
Neuroblastoma
Neuroendocrine Tumors
Parkinson Disease
Brain Glioma

DRUG: 18F-DOPA

Pro00055342

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-02-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-01-06
First Submitted that Met QC Criteria 2017-02-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-01-10
First Posted (ACTUAL) 2017-02-03	Results First Posted N/A	Last Verified 2022-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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

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

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

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Alberta Health services

Investigators

PRINCIPAL_INVESTIGATOR: Jonathan T Abele, MD, University of Alberta

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record