[18F]3F4AP Imaging for Multiple Sclerosis

Overseen By Kayla Cottiers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: Anticoagulants

Disqualifiers: Pregnant, Breastfeeding, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique called [18F]3F4AP to better understand its behavior in the body. It targets individuals with conditions like Multiple Sclerosis (MS), Alzheimer's Disease (AD), and other brain and nerve disorders. Participants will help researchers learn about the movement and effects of this imaging agent, potentially improving diagnosis and treatment. Ideal candidates have been diagnosed with one of these conditions and experience related symptoms in daily life. The study also needs healthy volunteers for comparison. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking anticoagulants (blood thinners), you cannot participate in the trial.

Is there any evidence suggesting that [18F]3F4AP is likely to be safe for humans?

Research has shown that [18F]3F4AP, a new imaging agent tested for multiple sclerosis and other conditions, has undergone safety studies in healthy individuals. One study examined how [18F]3F4AP moves through the body and its radiation effects. Researchers found it safe in the small group tested, with no major side effects reported. This suggests that [18F]3F4AP is well-tolerated in humans so far. However, as it remains in early trials, further research is needed to confirm its safety in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the [18F]3F4AP imaging trial because it offers a groundbreaking method to visualize nerve damage in multiple sclerosis (MS) and other neurological conditions. Unlike traditional imaging methods like MRI, which primarily show structural changes, [18F]3F4AP uses a radiolabeled compound that binds to damaged nerves, allowing for a more precise visualization of nerve activity and dysfunction. This could lead to earlier detection and a better understanding of disease progression, potentially guiding more personalized treatment plans. It's a promising step forward in how we understand and manage neurological disorders.

What evidence suggests that [18F]3F4AP might be an effective imaging agent for demyelinating diseases?

Research has shown that [18F]3F4AP is a promising tool for imaging diseases like Multiple Sclerosis (MS) and Spinal Cord Injury (SCI), where nerve coverings are damaged. In this trial, participants with MS, SCI, and other conditions will undergo PET scanning sessions using [18F]3F4AP. This PET tracer can highlight differences in brain lesions, which are damaged areas in the brain. [18F]3F4AP easily reaches the brain and is sensitive to changes in these lesions, making it useful for tracking disease progress. In MS, it aids in understanding how the protective nerve covering, called myelin, repairs itself, which is crucial for finding effective treatments. For SCI, this tracer focuses on specific parts of nerve cells, offering a new way to see and study the damage. Its ability to identify nerve damage is supported by clear and consistent results from previous studies. ^{1 3 6 7 8}

Who Is on the Research Team?

Georges El Fakhri, PhD, DABR

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for healthy volunteers and individuals with conditions affecting brain or spinal cord myelin, such as mild cognitive impairment, Alzheimer's Disease, Multiple Sclerosis, Spinal Cord Injury, and Spinal Radiculopathy.

Inclusion Criteria

I am between 18 and 89 years old.

I understand the study and can give my consent.

Must be in good health

Exclusion Criteria

Pregnant or breastfeeding

Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months)

I do not have any serious illnesses or unstable health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Sessions

Participants undergo up to three PET scanning sessions to assess pharmacokinetics and demyelination

Varies per participant

Up to 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging sessions

5 years

What Are the Treatments Tested in This Trial?

Interventions

• [18F]3F4AP

Trial Overview The study tests the pharmacokinetics of three imaging compounds ([18F]3F4AP, [18F]MK6240, [11C]PIB) to assess their ability to visualize demyelination in various neurological conditions.

How Is the Trial Designed?

Group I: Spinal radiculopathy (SR) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group II: Spinal Cord Injury (SCI) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group III: Multiple Sclerosis (MS) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group IV: Mild Cognitive Impairment (MCI) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group V: Alzheimer's Disease (AD) Experimental Treatment 3 Interventions

n = 15 - up to three PET scanning sessions.

Group VI: Healthy Control Active Control 3 Interventions

n = 30 - up to three PET scanning sessions.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40759830/

First evaluation in multiple sclerosis using PET tracer [18F ... First evaluation in multiple sclerosis using PET tracer [18F]3F4AP demonstrates heterogeneous binding across lesions · Authors · Affiliations.

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/2/293

Imaging Demyelinated Axons After Spinal Cord Injuries with ... In this study, we introduce a novel approach using the PET tracer, 3-[18F]fluoro-4-aminopyridine ([18F]3F4AP), specifically targeting K+ ...

3. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/new-pet-tracer-can-reveal-insights-into-multiple-sclerosis

New PET Tracer Can Reveal Deeper Insights into Multiple ... Using [18F]3F4AP alongside MRI may be helpful in studying the process of repairing myelin in MS, especially for clinical trials. Q: What ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04699747?tab=table

Investigating the Utility of Demyelination Tracer [18F] ... First evaluation in multiple sclerosis using PET tracer [18F]3F4AP demonstrates heterogeneous binding across lesions. Eur J Nucl Med Mol Imaging. 2025 Aug 5 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960894X24003937

Synthesis of K+ channel radioligand [18F]5-methyl-3-fluoro ... [18F]3F4AP exhibits high brain penetration, favorable kinetics for PET imaging, and high sensitivity to demyelinating lesions. However, recent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11800733/

Imaging Demyelinated Axons After Spinal Cord Injuries with ... [18F]3F4AP has demonstrated high sensitivity to demyelinated lesions in animal models of multiple sclerosis (27) and is currently under ...

7. link.springer.com link.springer.com/article/10.1007/s00259-022-05980-w

Human biodistribution and radiation dosimetry of the ... This study aimed to evaluate the biodistribution, safety, and radiation dosimetry of [18F]3F4AP in healthy human volunteers. Methods. Four ...

8. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/3f4ap_in_ms

Imaging the brain of multiple sclerosis subjects and healthy ... We are investigating a new imaging agent for PET called [18F]3F4AP that may provide new information about brain lesions in people with multiple sclerosis (MS).