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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
18F-DOPA
DrugAll participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study
Furosemide Injection
DrugSome participants will receive an intravenous injection of furosemide (40mg, single dose)
Treatment groups
Trial outcomes
Primary outcomes
Minimum lesion detectibility (size)
Measurement of size (mm) of the three smallest lesions
Assessment of bladder activity
Measurement of standardized uptake value (SUV) for urinary bladder activity
Assessment of bladder activity artifact
Subjective scoring (0-2 scale) of image artifact in pelvis related to bladder activity
Minimum lesion detectability (SUV)
Measurement of the standardized uptake value (SUV) of the three smallest lesions
Secondary outcomes
Gallbladder activity pattern
Assessment of SUVmax of various segments of the biliary tree at different time points after 18F-DOPA injection using a subgroup of participants (64 total)
Gallbladder disease questionnaire
All participants will complete a questionnaire regarding a history of gallbladder disease
Sponsors and contacts
Click on the lead sponsor to view all of their trials.