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

Primary Purpose

Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
18F-DOPA
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Hyperinsulinism focused on measuring 18F-DOPA PET/CT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alberta Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DOPA scan

Arm 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).

Outcomes

Primary Outcome Measures

Immediate safety evaluation
Clinical screen for adverse reactions to 18F-DOPA injection

Secondary Outcome Measures

Delayed safety evaluation
A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection
Delayed safety evaluation - referring physician
Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA 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
Perceived clinical benefit
Questionnaire for referring physician to assess perceived clinical benefit of scan

Full Information

First Posted
February 1, 2017
Last Updated
January 6, 2022
Sponsor
University of Alberta
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT03042416
Brief Title
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Official Title
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: Pediatric patients with congenital hyperinsulinism Pediatric patients with neuroblastoma Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor Adult patients with a clinical suspicion of Parkinson's disease 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma
Keywords
18F-DOPA PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-DOPA scan
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
18F-DOPA
Intervention Description
18F-DOPA intravenous injection single dose
Primary Outcome Measure Information:
Title
Immediate safety evaluation
Description
Clinical screen for adverse reactions to 18F-DOPA injection
Time Frame
Within 1 hour of injection
Secondary Outcome Measure Information:
Title
Delayed safety evaluation
Description
A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection
Time Frame
10-14 days after injection
Title
Delayed safety evaluation - referring physician
Description
Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection
Time Frame
6 months after injection
Title
Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected
Description
Scan interpreter will evaluate the distribution of tracer and comment if expected
Time Frame
Within 3 days after injection
Title
Perceived clinical benefit
Description
Questionnaire for referring physician to assess perceived clinical benefit of scan
Time Frame
6 months after injection

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan T Abele, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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