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NCT Number: NCT06999434

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

The overall objective is to obtain an assessment of the pharmacokinetics of [18F]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).

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Key information

Conditions

Demyelinating Disorders Alzheimer Disease Alzheimer's Disease (AD) Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases MCI MS (Multiple Sclerosis) Mental Disorders Multiple Sclerosis Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases SCI - Spinal Cord Injury Spinal Cord Diseases Spinal Cord Injuries Spinal Radiculopathy Tauopathies Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University PET Center

New Haven, Connecticut, 06510, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Male and Female subjects must be ≥18 and <90 years of age;
  • Able to understand and provide informed consent prior to study procedures
  • Must be in good health

Exclusion:

  • Less than 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 current PET Center guidelines (i.e. 50 mSv in the prior 12 months);
  • History of a bleeding disorder or are currently taking anticoagulants.

Treatment and study plan

[ 18F]3F4AP

Drug

PET Scan #3

[18F]MK6240

Drug

PET Scan #2

[11C]PIB

Drug

PET Scan #1

Primary outcomes

  1. Tracers volume of distribution (VT)

    Time frame: 5 years

    PET images measured with [ 18F]3F4AP will quantify demyelination, those obtained with [18F]MK6240 will quantify tau burden and those obtained with [11C]PiB will reflect amyloid burden.

    PET images acquired with [18F]3F4AP, [18F]MK6240 and [11C]PiB, will measure the tracers volume of distribution (VT).

  2. Distribution volume ratio (DVR)

    Time frame: 5 years

    PET images acquired with [18F]3F4AP, [18F]MK6240 and [11C]PiB, will measure the tracers distribution volume ratio (DVR).

  3. Binding potential (BPND)

    Time frame: 5 years

    PET images acquired with [18F]3F4AP, [18F]MK6240 and [11C]PiB, will measure the tracers binding potential (BPND).

  4. Demyelination

    Time frame: 5 years

    [18F]3F4AP will be used to measure demyelination. On the MR images, after co-registration and alignment, signal from pre- and post-contrast T1-weighted images, T2-weighted image, ratio between T1- and T2-weighted images (T1/T2) will be calculated to assess demyelination and white matter lesion (WML) on MR sequences.

  5. Tau burden

    Time frame: 5 years

    [18F]MK6240 will be used to measure Tau burden.

  6. Amyloid burden

    Time frame: 5 years

    [11C]PiB will reflect amyloid burden.

  7. Tracer rate constant

    Time frame: 5 years

    The tracer rate constant for transfer from arterial plasma to tissue K1 and relative delivery R1 will also be estimated using tracer kineticmodeling technique, to provide measures of cerebral perfusion or CBF.

  8. Associations between imaging modalities and biomarkers.

    Time frame: 5 years

    The Pearson correlation coefficient r will be used to assess the strength of the linear correlations between outcome measures. A P value of 0.05 or less will be considered statistically significant.

Secondary outcomes

  1. Measure of brain atrophy

    Time frame: 5 years

    T1 images segmented and parcellated using FreeSurfer will be used to calculate cortical volumes, including the total cortical volume but also the hippocampal volume and will serve as proxies for neocortical and allocortical atrophy.

  2. Measure of cerebrovascular burden

    Time frame: 5 years

    volume of White matter hyperintensities (WMH) on T1 images or T2 images

  3. Measure of White matter lesions (WML)

    Time frame: 5 years

    The total WML load score will be calculated as the sum of the frequency of lesions multiplied by their volume.

  4. MR/MRSI images

    Time frame: 5 years

    Evaluated to determine the effect of pulse sequence parameters and/or hardware configuration on image quality. The images acquired with different pulse sequence parameters or MR hardware configurations will be compared. Comparison of the MR images entails comparing the result of specific image quality measures such as signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) as well as the level of image artifacts

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Cottiers

CONTACT

[email protected]

203-737-7496

Shannan Henry

CONTACT

[email protected]

+1 (203) 737-5278

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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