18F-DOPA II - PET Imaging Optimization

Recruiting now · Phase 3

Conditions studied: Congenital Hyperinsulinism, Neuroblastoma, Parkinson Disease, Lewy Body Disease, Neuroendocrine Tumors, Brain Tumor

In brief

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.

Key facts

Study ID

NCT04706910

Run by

University of Alberta

People needed

800

Starts

2021-01-20

Expected to finish

2027-12-01

Last updated by the study team

2026-02-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Unable to obtain consent
• Weight >225 kg (weight limitation of PET/CT scanner)
• 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)
• Pregnancy

Where it is running

• WC Mackenzie Health Science Centre / University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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