Ultralow Dose PET Imaging for Parkinson's Disease and Brain Tumors

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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?

This trial tests a new imaging technique for detecting and monitoring Parkinson’s disease and certain brain tumors. It uses a much lower radiation dose than usual methods. Participants will receive a small amount of a radioactive substance, 18F-FDOPA (a tracer used in PET scans), and undergo a PET scan to determine if researchers can improve the imaging process. Suitable candidates include those diagnosed with Parkinson’s disease or specific brain tumors, who do not have severe claustrophobia or conditions that make long scans uncomfortable. As a Phase 2 trial, this research measures how well the imaging technique works in an initial, smaller group, offering participants a chance to contribute to advancements in medical imaging.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that treatments interfering with the study may be excluded. It's best to discuss your medications with the study team.

What prior data suggests that this ultralow dose PET imaging technique is safe for detecting Parkinsonian syndromes and brain tumors?

Previous studies have shown that 18F-FDOPA PET imaging is generally safe. Most people tolerate it well, and serious side effects rarely occur. The scan uses low radiation, but there is a small risk from exposure, so the lowest possible dose is used. The FDA has approved this technique for certain conditions, such as Parkinson's disease, indicating its safety for those uses. Overall, research suggests that 18F-FDOPA is a well-tolerated option for imaging various brain conditions.12345

Why are researchers excited about this trial?

Researchers are excited about ultralow dose 18F-FDOPA PET imaging because it offers a new approach to diagnosing Parkinson's disease and brain tumors with significantly reduced radiation exposure. Unlike standard PET imaging, which uses higher doses of radiotracers, this method reduces radiation doses by 10-100 times while still aiming to maintain high-quality images. This advancement could make the diagnostic process safer for patients, especially those who require repeated imaging, and could lead to more precise timing and reconstruction of images.

What evidence suggests that this ultralow dose PET imaging technique is effective for detecting Parkinsonian syndromes and brain tumors?

This trial will evaluate ultralow dose 18F-FDOPA PET imaging for Parkinson's disease and brain tumors. Studies have shown that 18F-FDOPA PET imaging effectively diagnoses and manages these conditions. Research indicates that 18F-FDOPA surpasses other imaging methods in accuracy, particularly for identifying low-grade tumors and assessing recurring tumors. The FDA has approved 18F-FDOPA for early Parkinson's disease diagnosis, highlighting its proven effectiveness. This imaging technique visualizes the brain's dopamine pathways, crucial for understanding conditions like Parkinson's. Overall, 18F-FDOPA PET imaging is a well-supported tool for evaluating both Parkinson's and brain tumors.12678

Are You a Good Fit for This Trial?

This trial is for adults age 18 or older, including those with brain tumors, Parkinson's disease, neuroendocrine tumors, and healthy volunteers. Participants must not be pregnant or breastfeeding and need to be able to give informed consent.

Inclusion Criteria

2. ability to provide informed consent and comply with study procedures.
* must not be pregnant or breastfeeding.
I am 18 years old or older.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants are injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours to evaluate image quality and optimize timing and reconstruction.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, with data aggregated annually for up to 5 years.

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-FDOPA

Trial Overview

Researchers are testing an ultralow dose PET scan using a radioactive tracer called 18F-FDOPA. The study aims to see if they can get good images of the brain or certain tumors while exposing people to much less radiation than usual.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ultralow dose 18F-FDOPA imaging groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Akiva Mintz

Lead Sponsor

Trials
1
Recruited
40+

Citations

NCT07542158 | Ultralow Dose PET Imaging of 18F-FDOPA

This research study aims to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, ...

Usefulness of 18F-FDOPA PET for the management of primary ...

F-FDOPA PET/CT could be helpful in the initial diagnosis of primary brain tumors, in addition to MRI. These two imaging modalities demonstrated that they could ...

The FDA approves F-Dopa PET imaging to aid in early ...

The FDA approves F-Dopa PET imaging to aid in early diagnosis of Parkinson's disease. The FDA recently approved Fluorodopa F18 (F-Dopa), a ...

Safety and Effectiveness of 18f-Fdopa Pet/Pet-Ct for ...

CONCLUSIONS: 18F-FDOPA PET/PET-CT was evaluated to be a safety and effectiveness for differentiating between patients with PD and non PD. Also, this technique ...

Ultralow Dose PET Imaging for Parkinson's Disease and ...

This Phase 2 medical study run by Akiva Mintz needs participants to evaluate whether 18F-FDOPA will have tolerable side effects & efficacy for patients with ...

Prospective F-18 FDOPA PET Imaging Study in Human PD

F-18 FDOPA PET scan has very high specificity and PPV, which provide evidence that the test performs well in a patient referral population where ...

FLUORODOPA F 18 Injection - accessdata.fda.gov

Radiation risks: Use smallest dose necessary for imaging and ensure safe handling to protect the patient and healthcare worker from radiation exposure. (5.1).

[18F]DOPA PET in Parkinson's Disease Clinical Trials

PET scanning using [18F]DOPA is generally considered safe. Adverse reactions are rare, the dosage is low, and due to the relatively short half- ...