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18F-DOPA PET/CT Imaging Optimization

Phase 3
Recruiting
Led By Jonathan Abele, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor
Pediatric patients (less than 18 years old) with congenital hyperinsulinism
Must not have
Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session
Weight >225 kg (weight limitation of PET/CT scanner)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month of pet/ct scan
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at using 18F-DOPA PET/CT imaging in specific patient populations to see if it can help optimize images and identify gallbladder activity patterns.

Who is the study for?
This trial is for children and adults with certain conditions like congenital hyperinsulinism, neuroendocrine tumors, brain tumors, Parkinson's disease or Lewy body dementia. It excludes pregnant individuals, those over 225 kg, patients who can't lie flat for the scan duration or give consent, and young kids who can't be sedated safely.
What is being tested?
The study tests how well a PET/CT imaging technique works using an injection of Furosemide and a radioactive drug called 18F-DOPA. The goal is to optimize images for better diagnosis in various diseases including brain tumors and Parkinson's.
What are the potential side effects?
Possible side effects from the Furosemide injection may include dehydration or electrolyte imbalance. The radioactive drug used in PET/CT scans has minimal side effects but might cause slight discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under or over 18 and may have a neuroendocrine tumor.
Select...
I am under 18 and have been diagnosed with congenital hyperinsulinism.
Select...
I am under 18 and have been diagnosed with neuroblastoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot lie flat for 20-30 minutes.
Select...
My weight is under 225 kg.
Select...
My child cannot lie flat for 20-30 minutes and cannot be sedated safely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month of pet/ct scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month of pet/ct scan for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of bladder activity
Assessment of bladder activity artifact
Minimum lesion detectability (SUV)
+1 more
Secondary study objectives
Gallbladder activity pattern
Gallbladder disease questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-DOPA injectionExperimental Treatment2 Interventions
All enrolled participants will receive an intravenous injection of the investigational 18F-DOPA radiopharmaceutical
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DOPA
2017
Completed Phase 3
~2080
Furosemide Injection
2023
Completed Phase 3
~170

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
942 Previous Clinical Trials
433,609 Total Patients Enrolled
Jonathan Abele, MDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
600 Total Patients Enrolled

Media Library

18F-DOPA Clinical Trial Eligibility Overview. Trial Name: NCT04706910 — Phase 3
Parkinson's Disease Research Study Groups: 18F-DOPA injection
Parkinson's Disease Clinical Trial 2023: 18F-DOPA Highlights & Side Effects. Trial Name: NCT04706910 — Phase 3
18F-DOPA 2023 Treatment Timeline for Medical Study. Trial Name: NCT04706910 — Phase 3
~152 spots leftby Dec 2025
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