18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
NCT ID: NCT03042416
Last Updated: 2022-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2017-06-29
2021-06-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
18F-DOPA II - PET Imaging Optimization
NCT04706910
A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas
NCT02104310
18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions
NCT04306484
18F-FDOPA PET in Neuroendocrine Tumours
NCT02431715
Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
NCT02539433
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
18F-DOPA
18F-DOPA intravenous injection single dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
18F-DOPA
18F-DOPA intravenous injection single dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alberta Health services
OTHER
University of Alberta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan T Abele, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00055342
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.