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Funding Research for Pediatric Brain Cancer

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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.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
Study Type

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.


Searching Both is inclusive of interventional and observational studies.

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

Trial ID:

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.

NCT03042416
Phase

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 3
Lead Sponsor

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

University of Alberta
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jonathan T Abele, MD
Principal Investigator Affiliation University of Alberta
Agency Class

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

OtherOther
Overall Status Recruiting
Countries Canada
Conditions

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

Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma
Arms & Interventions

Arms

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).

Interventions

Drug: - 18F-DOPA

18F-DOPA intravenous injection single dose

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G2B7

Site Contact

Jonathan Abele, MD

jabele@ualberta.ca

7804076907

Nearest Location

Site Contact

Jonathan Abele, MD

jabele@ualberta.ca

7804076907


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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other questions call

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