Optimizing PET Imaging with 18F-DOPA for Various Conditions

18F-DOPA II - PET Imaging Optimization

This study is testing if a special imaging technique using 18F-DOPA can help doctors see and understand conditions like congenital hyperinsulinism, neuroblastoma, neuroendocrine tumors, Parkinson's disease, and Lewy body dementia better in both kids and adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT04706910 on ClinicalTrials.gov

What this trial studies

This phase III interventional study focuses on optimizing 18F-DOPA PET/CT imaging for patients with congenital hyperinsulinism, neuroblastoma, neuroendocrine tumors, Parkinson's disease, and Lewy body dementia. The study will evaluate the imaging capabilities of 18F-DOPA, a tracer that mimics L-DOPA, to provide valuable insights into these conditions. It will involve both pediatric and adult patients, assessing the tracer's safety and efficacy in a local setting using advanced imaging technology. The primary objective is to enhance image quality, while secondary objectives include analyzing gallbladder activity patterns.

Who should consider this trial

Good fit: Ideal candidates include pediatric patients under 18 with congenital hyperinsulinism or neuroblastoma, and adults or pediatric patients with neuroendocrine tumors, Parkinson's disease, Lewy body dementia, or brain tumors.

Not a fit: Patients who are unable to provide consent, weigh over 225 kg, or cannot lie flat for the duration of the PET-CT session may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic imaging techniques that enhance the detection and management of various neurological and endocrine disorders.

How similar studies have performed: Previous studies have demonstrated the safety and efficacy of 18F-DOPA as a diagnostic tracer, indicating potential for success in this optimized imaging approach.

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

Where this trial is running

Edmonton, Alberta

• WC Mackenzie Health Science Centre / University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Jonathan Abele, MD — University of Alberta
• Study coordinator: Jonathan Abele, MD

Conditions Congenital Hyperinsulinism; Neuroblastoma; Parkinson Disease; Lewy Body Disease; Neuroendocrine Tumors; Brain Tumor