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

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ClinicalTrials.gov Identifier: NCT03042416
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta

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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


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


Secondary Outcome Measures :
  1. Delayed safety evaluation [ Time Frame: 10-14 days after injection ]
    A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection

  2. Delayed safety evaluation - referring physician [ Time Frame: 6 months after injection ]
    Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection

  3. 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

  4. Perceived clinical benefit [ Time Frame: 6 months after injection ]
    Questionnaire for referring physician to assess perceived clinical benefit of scan



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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03042416     History of Changes
Other Study ID Numbers: Pro00055342
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
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
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
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents