Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042416
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE June 29, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
Immediate safety evaluation [ Time Frame: Within 1 hour of injection ]
Clinical screen for adverse reactions to 18F-DOPA injection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • Delayed safety evaluation [ Time Frame: 10-14 days after injection ]
    A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection
  • Delayed safety evaluation - referring physician [ Time Frame: 6 months after injection ]
    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 [ Time Frame: Within 3 days after injection ]
    Scan interpreter will evaluate the distribution of tracer and comment if expected
  • Perceived clinical benefit [ Time Frame: 6 months after injection ]
    Questionnaire for referring physician to assess perceived clinical benefit of scan
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Official Title  ICMJE 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Congenital Hyperinsulinism
  • Neuroblastoma
  • Neuroendocrine Tumors
  • Parkinson Disease
  • Brain Glioma
Intervention  ICMJE Drug: 18F-DOPA
18F-DOPA intravenous injection single dose
Study Arms  ICMJE 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).
Intervention: Drug: 18F-DOPA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan T Abele, MD 780-407-6907 jabele@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03042416
Other Study ID Numbers  ICMJE Pro00055342
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Alberta Health Services
Investigators  ICMJE
Principal Investigator: Jonathan T Abele, MD University of Alberta
PRS Account University of Alberta
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP