Clinical Trial Finder

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

Study 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.

Recuitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03042416

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of Alberta

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Not yet recruiting
Countries

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Jonathan T Abele, MD

780-407-6907

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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