NCT03042416 is a Phase 3 clinical trial of 18F-DOPA in Congenital Hyperinsulinism, sponsored by University of Alberta.

Who is sponsoring NCT03042416?

NCT03042416 is sponsored by University of Alberta.

What drugs are being tested in NCT03042416?

Interventions in NCT03042416: 18F-DOPA.

What condition does NCT03042416 study?

NCT03042416 studies Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma.

Is NCT03042416 still recruiting?

NCT03042416 is currently completed. Last updated 10 January 2022.

Last reviewed 2022-01-10 · How we verify

NCT03042416

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

Completed Phase 3 Last updated 10 January 2022

What this trial tests

Phase 3 trial testing 18F-DOPA in Congenital Hyperinsulinism in 400 participants. Completed in 2 June 2021.

Timeline

29 June 2017

Primary endpoint
5 March 2021

2 June 2021

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	400
Start date	29 June 2017
Primary completion	5 March 2021
Estimated completion	2 June 2021
Sites	1 location across Canada

Drugs / interventions tested

18F-DOPA — full drug profile →

Conditions studied

Congenital Hyperinsulinism — all drugs for Congenital Hyperinsulinism →
Neuroblastoma — all drugs for Neuroblastoma →
Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →
Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

University of Alberta

Who can join

Eligibility, any sex, with Congenital Hyperinsulinism or Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor 4. Adult patients with a clinical suspicion of Parkinson's disease 5. Pediatric or Adult patients with primary brain tumors This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Novel Tracers and Radionuclides in PET Imaging.
Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012

Verify or expand the search:

Other trials of 18F-DOPA

Trials testing the same drug.

NCT03648905 — Clinical Laboratory Evaluation of Chronic Autonomic Failure · active not recruiting
NCT02856347 — Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Lev · NA · completed
NCT02019706 — Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome · Phase 2 · recruiting
NCT00001849 — New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome · Phase 2 · completed
NCT00001277 — Studies of Elevated Parathyroid Activity · Phase 2 · completed

Other recruiting trials for Congenital Hyperinsulinism

Currently open trials in the same condition.

NCT06208215 — RZ358 Treatment for Congenital Hyperinsulinism · Phase 3 · active not recruiting
NCT04732416 — HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) · Phase 2 · recruiting
NCT03941236 — Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism · Phase 3 · active not recruiting
NCT04205604 — 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism · Phase 2 · recruiting

Other University of Alberta trials

Trials by the same sponsor.

NCT03240900 — Electrical Stimulation for Improving Postoperative Breast Sensation · NA · not yet recruiting
NCT04231760 — The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD · Phase 1, PHASE2 · not yet recruiting
NCT06649604 — Reducing Pain From Retinal Laser With Vibrational Stimulation · NA · not yet recruiting
NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
NCT06920914 — Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03042416 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alberta
Last refreshed: 10 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03042416.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing