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

This study is currently recruiting participants.
Verified February 2017 by University of Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT03042416
First Posted: February 3, 2017
Last Update Posted: May 3, 2017
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.
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta
  Purpose

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.


Condition Intervention Phase
Congenital Hyperinsulinism Neuroblastoma Neuroendocrine Tumors Parkinson Disease Brain Glioma Drug: 18F-DOPA Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Immediate safety evaluation [ Time Frame: Within 1 hour of injection ]
    Clinical screen for adverse reactions to 18F-DOPA injection


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
Anticipated Study Start Date: May 1, 2017
Estimated Study Completion Date: December 31, 2022
Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042416


Contacts
Contact: Jonathan T Abele, MD 780-407-6907 jabele@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Jonathan Abele, MD    7804076907    jabele@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Alberta Health Services
Investigators
Principal Investigator: Jonathan T Abele, MD University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03042416     History of Changes
Other Study ID Numbers: Pro00055342
First Submitted: February 1, 2017
First Posted: February 3, 2017
Last Update Posted: May 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:
18F-DOPA PET/CT

Additional relevant MeSH terms:
Hyperinsulinism
Congenital Hyperinsulinism
Parkinson Disease
Neuroblastoma
Neuroendocrine Tumors
Carcinoid Tumor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia