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RECRUITINGPhase 3INTERVENTIONAL

18F-DOPA II - PET Imaging Optimization

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 1. Unable to obtain consent 2. Weight \>225 kg (weight limitation of PET/CT scanner) 3. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session. 4. 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). 5. Lack of intravenous access 6. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only) 7. Pregnancy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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. Exclusion Criteria: 1. Unable to obtain consent 2. Weight \>225 kg (weight limitation of PET/CT scanner) 3. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session. 4. 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). 5. Lack of intravenous access 6. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only) 7. Pregnancy

Treatments Being Tested

DRUG

18F-DOPA

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

DRUG

Furosemide 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