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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorYale University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Less than 18 years of age;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • [ 18F]3F4AP

    Drug

    PET Scan #3

  • [18F]MK6240

    Drug

    PET Scan #2

  • [11C]PIB

    Drug

    PET Scan #1

Treatment groups

105 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Healthy ControlActive comparator 3 interventions
Group B: Alzheimer's Disease (AD)Experimental treatment 3 interventions
Group C: Mild Cognitive Impairment (MCI)Experimental treatment 3 interventions
Group D: Multiple Sclerosis (MS)Experimental treatment 3 interventions
Group E: Spinal Cord Injury (SCI)Experimental treatment 3 interventions
Group F: Spinal radiculopathy (SR)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Tracers volume of distribution (VT)

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).

Time frame
5 years
2

Distribution volume ratio (DVR)

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

Time frame
5 years
3

Binding potential (BPND)

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

Time frame
5 years
4

Demyelination

\[18F\]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.

Time frame
5 years

Secondary outcomes

1

Measure of brain atrophy

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.

Time frame
5 years
2

Measure of cerebrovascular burden

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

Time frame
5 years
3

Measure of White matter lesions (WML)

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

Time frame
5 years
4

MR/MRSI images

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

National Institute on Aging (NIA)

Collaborator