RecruitingPhase 3NCT04706910

18F-DOPA II - PET Imaging Optimization


Sponsor

University of Alberta

Enrollment

800 participants

Start Date

Jan 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is optimizing PET scan imaging using a tracer called 18F-DOPA, which helps visualize certain types of tumors and brain conditions by showing how dopamine is processed in the body. It is open to both children and adults depending on the condition being studied. **You may be eligible if...** - You are a child (under 18) with congenital hyperinsulinism (a rare condition causing too much insulin) or neuroblastoma (a childhood cancer) - You are a child or adult with a known or suspected neuroendocrine tumor - You are an adult (18+) with suspected Parkinson's disease or Lewy body dementia - You are a child or adult with a brain tumor **You may NOT be eligible if...** - You are unable to provide consent (or a guardian cannot) - You weigh more than 225 kg (scanner weight limit) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-DOPA

All participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study

DRUGFurosemide Injection

Some participants will receive an intravenous injection of furosemide (40mg, single dose)


Locations(1)

WC Mackenzie Health Science Centre / University of Alberta Hospital

Edmonton, Alberta, Canada

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NCT04706910


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