18F-DOPA II - PET Imaging Optimization

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Alberta

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 18F-DOPA

    Drug

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

  • Furosemide Injection

    Drug

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

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: 18F-DOPA injectionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Minimum lesion detectibility (size)

Measurement of size (mm) of the three smallest lesions

Time frame
Within 1 month of PET/CT scan
2

Assessment of bladder activity

Measurement of standardized uptake value (SUV) for urinary bladder activity

Time frame
Within 1 month of PET/CT scan
3

Assessment of bladder activity artifact

Subjective scoring (0-2 scale) of image artifact in pelvis related to bladder activity

Time frame
Within 1 month of PET/CT scan
4

Minimum lesion detectability (SUV)

Measurement of the standardized uptake value (SUV) of the three smallest lesions

Time frame
Within 1 month of PET/CT scan

Secondary outcomes

1

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)

Time frame
Within 3 months of PET/CT scan
2

Gallbladder disease questionnaire

All participants will complete a questionnaire regarding a history of gallbladder disease

Time frame
At the time of enrollment

Other outcomes

Sponsors and contacts

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