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Completed

NCT Number: NCT03042416

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.

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Key information

Conditions

Congenital Hyperinsulinism Basal Ganglia Diseases Brain Diseases Brain Glioma Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Infant, Newborn, Diseases Metabolic Diseases Movement Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroblastoma Neurodegenerative Diseases Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neuroendocrine Tumors Nutritional and Metabolic Diseases Pancreatic Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-DOPA

Drug

18F-DOPA intravenous injection single dose

Primary outcomes

  1. Immediate safety evaluation

    Time frame: Within 1 hour of injection

    Clinical screen for adverse reactions to 18F-DOPA injection

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Health services

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2017
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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