18F-DOPA II - PET Imaging Optimization (NCT04706910) | Clinical Trial Compass
RecruitingPhase 3
18F-DOPA II - PET Imaging Optimization
Canada800 participantsStarted 2021-01-20
Plain-language summary
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations:
1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism.
2. Pediatric patients (less than 18 years old) with neuroblastoma.
3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.
4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.
5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.
Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pediatric patients (less than 18 years old) with congenital hyperinsulinism.
. Pediatric patients (less than 18 years old) with neuroblastoma.
. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.
. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.
. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.
Exclusion criteria
. Unable to obtain consent
. Weight \>225 kg (weight limitation of PET/CT scanner)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session.
. Young pediatric patients (less than 13 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).
. Lack of intravenous access
. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)