NCT04706910 18F-DOPA II - PET Imaging Optimization
| NCT ID | NCT04706910 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Alberta |
| Condition | Congenital Hyperinsulinism |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2021-01-20 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 800 participants in total. It began in 2021-01-20 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jonathan Abele, MD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT04706910 clinical trial?
This trial is open to participants of all sexes, studying Congenital Hyperinsulinism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04706910 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 800 participants.
Is NCT04706910 currently recruiting?
Yes, NCT04706910 is actively recruiting participants. Contact the research team at jabele@ualberta.ca for enrollment information.
Where is the NCT04706910 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT04706910 clinical trial?
NCT04706910 is sponsored by University of Alberta. The principal investigator is Jonathan Abele, MD at University of Alberta. The trial plans to enroll 800 participants.