FDA Approved Diagnostic Tool for Parkinson’s: Fluorodopa F 18

Fluorodopa F 18 is a new tool for diagnosing Parkinson’s disease (PD). It helps make clearer pictures of nerve cells during brain scans.^1-2

The new drug was developed at The Feinstein Institutes for Medical Research in New York. This new tool will be used to improve the diagnosis of PD and other Parkinson's-related syndromes.^3-4

How does Fluorodopa F 18 work?

Fluorodopa F 18 is a clear liquid drug with a radioactive tracer. This means it is injected into a vein during a PET (Positron Emission Tomography) scan. The PET scan is a non-invasive imaging test.⁵ It can help doctors evaluate a disease of the organs at the cellular level.³ Fluorodopa F 18 makes it easier to see the affected area of the brain.

People with Parkinson’s disease do not make enough of the neurotransmitter dopamine. If there is a loss of these dopamine-making nerves in the brain, the signal Fluorodopa F 18 makes will be lower.³

Dr. Thomas Chaly and his team in New York have been working to develop a safe and effective imaging agent to be used in people who might have Parkinson’s. The goal is to help make an earlier and more accurate diagnosis of Parkinson’s.^1-5 They found that Fluorodopa F 18 used along with a PET scan makes the brain images clearer. This helps doctors to make a more accurate diagnosis.¹ They can see any damaged or lost nerve cells in the brain.^1,4

Things to know about Fluorodopa F 18

The US Food and Drug Administration (FDA) approval was based on a small study of 56 people.^4-5 During the study, each person got one dose of Fluorodopa F 18 before having a PET scan. The images were then read by 3 readers who did not know anything about each person’s condition. The researchers look at the accuracy of the images made with the new drug. They then looked to find any nerve damage or nerve loss in people who had a Parkinson’s diagnosis 6-9 months after imaging.¹

What are the possible side effects of Fluorodopa F 18?

The study showed no difference in effectiveness based on age or gender. There were no side effects reported during the clinical trial and no known limits to who can use this drug.²

Future use of Fluorodopa F 18

Imaging centers in the United States can now use Fluorodopa F 18 as part of their regular imaging process. It is considered safe and effective. It should be used with other tools to diagnose Parkinson’s. Better imaging may help people get a more accurate and earlier Parkinson’s diagnosis.⁴

Fluorodopa F 18 can also be used as part of a follow-up plan. The images created using Fluorodopa F 18 can help doctors follow disease progression. This can be helpful in treating people with Parkinson’s.^3-4

For more details, read the full prescribing information for Fluorodopa F 18.