[18F]3F4AP Imaging for Multiple Sclerosis

Overseen ByKayla 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 GroupAll trial participants will receive the active study treatment (no placebo)

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.

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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?

Treatment groups

Experimental Treatment

Active Control

Group I: Spinal radiculopathy (SR)Experimental Treatment3 Interventions