800 Participants Needed

18F-DOPA PET/CT Imaging Optimization

JA
Overseen ByJonathan Abele, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is 18F-DOPA PET/CT imaging safe for humans?

18F-DOPA has been used safely for many years in imaging for Parkinson's disease and neuroendocrine tumors. Some formulations may cause a mild burning sensation at the injection site, but studies have shown that new formulations are well-tolerated in cell and animal tests.12345

How does the drug 18F-DOPA differ from other treatments for neuroendocrine tumors?

18F-DOPA is unique because it is a radiotracer used in PET/CT imaging to detect and manage neuroendocrine tumors by mimicking the natural amino acid L-DOPA, which is taken up by specific transporters in the body. This allows for precise imaging of tumor activity, which is different from traditional treatments that may not provide such detailed visualization.15678

What data supports the effectiveness of the drug 18F-DOPA in the clinical trial?

Research shows that 18F-DOPA PET imaging is useful for detecting and managing brain tumors, movement disorders, and neuroendocrine tumors. It has been used effectively in imaging for Parkinson's disease and carcinoid tumors, helping to locate tumors more accurately than some traditional methods.125910

Who Is on the Research Team?

Dr. Jonathan Abele : FRCPC | MIC ...

Jonathan Abele, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am under or over 18 and may have a neuroendocrine tumor.
I am an adult suspected to have Parkinson's disease or Lewy body dementia.
I am under 18 and have been diagnosed with congenital hyperinsulinism.
See 1 more

Exclusion Criteria

I cannot lie flat for 20-30 minutes.
You do not have a way for the study drug to be given through a vein.
Unable to obtain consent
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Imaging and Assessment

Participants receive an 18F-DOPA PET/CT scan to assess image optimization and gallbladder activity patterns

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1 month
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-DOPA
  • Furosemide Injection
Trial Overview 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Published Research Related to This Trial

F-DOPA PET/CT imaging shows minimal physiological uptake in the brain, except for the basal ganglia, while significant uptake is observed in the liver, pancreas, and urinary system, indicating its potential utility in diagnosing various conditions.
Incidental findings of F-DOPA uptake occurred in 5.5% of patients, often linked to inflammation or benign tumors, highlighting the importance of correlating imaging results with other diagnostic methods for accurate interpretation.
18F-DOPA PET/CT Physiological Distribution and Pitfalls: Experience in 215 Patients.Calabria, FF., Chiaravalloti, A., Jaffrain-Rea, ML., et al.[2018]
The new 18F-labeled l-DOPA analogue, [18F]FPDOPA, was successfully synthesized with a good yield and specific activity, making it a promising candidate for PET imaging of tumors.
In vivo studies showed that [18F]FPDOPA accumulates significantly in various tumor types, indicating its potential as a more effective PET tracer for brain tumors compared to the commonly used [18F]FDG.
Radiosynthesis and biological evaluation of N-(2-[18F]fluoropropionyl)-3,4-dihydroxy-l-phenylalanine as a PET tracer for oncologic imaging.Tang, C., Nie, D., Tang, G., et al.[2018]
The new formulations of 6-[18F]fluoro-l-dihydroxyphenylalanine (18F-DOPA) maintain chemical stability at a pH of 5.0, which eliminates the need for pH adjustment before injection, potentially reducing discomfort for patients.
In vitro tests on various cell lines and in vivo studies in rats indicate that these new formulations are well-tolerated, suggesting they are safe for further evaluation in clinical settings.
Pharmaceutical development of novel lactate-based 6-fluoro-l-DOPA formulations.Denora, N., Lopedota, A., de Candia, M., et al.[2017]

Citations

18F-DOPA PET/CT Physiological Distribution and Pitfalls: Experience in 215 Patients. [2018]
Radiosynthesis and biological evaluation of N-(2-[18F]fluoropropionyl)-3,4-dihydroxy-l-phenylalanine as a PET tracer for oncologic imaging. [2018]
Pharmaceutical development of novel lactate-based 6-fluoro-l-DOPA formulations. [2017]
Staging of carcinoid tumours with 18F-DOPA PET: a prospective, diagnostic accuracy study. [2022]
Prospective F-18 FDOPA PET Imaging Study in Human PD. [2023]
Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease. [2022]
In vivo biodistribution of no-carrier-added 6-18F-fluoro-3,4-dihydroxy-L-phenylalanine (18F-DOPA), produced by a new nucleophilic substitution approach, compared with carrier-added 18F-DOPA, prepared by conventional electrophilic substitution. [2022]
GMP production of 6-[18F]Fluoro-L-DOPA for PET/CT imaging by different synthetic routes: a three center experience. [2021]
Overexpression of L-Type Amino Acid Transporter 1 (LAT1) and 2 (LAT2): Novel Markers of Neuroendocrine Tumors. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Correlation of 6-18F-fluoro-L-dopa PET uptake with proliferation and tumor grade in newly diagnosed and recurrent gliomas. [2016]
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