Recruiting
Phase 3

18F-DOPA

Sponsor:

University of Alberta

Code:

NCT04706910

Conditions

Congenital Hyperinsulinism

Neuroblastoma

Parkinson Disease

Lewy Body Disease

Neuroendocrine Tumors

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

18F-DOPA

Furosemide Injection

Study Details

Brief 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.

Conditions

Congenital Hyperinsulinism

Neuroblastoma

Parkinson Disease

Lewy Body Disease

Neuroendocrine Tumors

Study ID

NCT04706910

Start date

Jan 20, 2021

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

800 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-DOPA injection

All enrolled participants will receive an intravenous injection of the investigational 18F-DOPA radiopharmaceutical

Interventions

18F-DOPA

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

Furosemide Injection

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

Primary outcome measure

  • Minimum lesion detectibility (size) [ Time Frame: Within 1 month of PET/CT scan ]
  • Assessment of bladder activity [ Time Frame: Within 1 month of PET/CT scan ]
  • Assessment of bladder activity artifact [ Time Frame: Within 1 month of PET/CT scan ]
  • Minimum lesion detectability (SUV) [ Time Frame: Within 1 month of PET/CT scan ]

Central Contacts and Locations

Central contacts

Jonathan Abele, MD

1-780-407-6907jabele@ualberta.ca

Locations

WC Mackenzie Health Science Centre / University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Jonathan Abele, MD

780-407-6907jabele@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-02-09.