Actively Recruiting

Phase 1
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID06999434

Exploring the Utility of [18F]3F4AP for Demyelination Imaging

Led by Yale University · Updated on 2025-05-31

105

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the pharmacokinetics of [18F]3F4AP, a tracer used in PET scans, in healthy adults and people with demyelinating disorders such as mild cognitive impairment (MCI), Alzheimer's Disease, Multiple Sclerosis, Spinal Cord Injury, and Spinal Radiculopathy. This Phase 1 trial aims to better understand how this tracer distributes in the body and how it relates to disease markers like demyelination, tau, and amyloid burdens. Participants will undergo up to three PET scan sessions using three different tracers: [11C]PIB, [18F]MK6240, and [18F]3F4AP. The study groups include healthy controls and people diagnosed with the listed demyelinating conditions. Each group will have multiple PET scans to capture various imaging measures related to brain pathology and disease progression. During the study, participants will have brain imaging sessions to assess tracer distribution, brain atrophy, cerebrovascular burden, and white matter lesions. Researchers will evaluate multiple biomarkers and imaging outcomes over five years. The study involves no randomization or masking, and participants will be monitored for safety and imaging results throughout the trial.

CONDITIONS

Brief Title

Exploring the Utility of [18F]3F4AP for Demyelination Imaging

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female subjects aged 18 to under 90 years
  • Able to understand and provide informed consent before study procedures
  • Must be in good health
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant or breastfeeding
  • Any significant systemic illness or unstable medical condition
  • Pre-existing medical conditions or claustrophobic reactions
  • Research-related radiation exposure exceeds PET Center guidelines (over 50 mSv in prior 12 months)
  • History of bleeding disorder or currently taking anticoagulants

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Duration varies depending on scheduling of up to three PET scans

Participants undergo up to three PET scanning sessions using different imaging tracers to evaluate brain conditions.

Up to 3 visits for PET scans

Long-term Monitoring

Duration - 5 years

Participants are monitored over 5 years to assess imaging outcomes such as demyelination and brain pathology.

Periodic visits over 5 years for imaging and assessments

Trial Site Locations

Total: 1 location

1

Yale University PET Center

New Haven, Connecticut, United States, 06510

Actively Recruiting

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Research Team

S

Shannan Henry

K

Kayla Cottiers

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

6

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