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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
105
Yale University PET Center
New Haven, Connecticut, United States
RECRUITINGTracers 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
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
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
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
Tau burden
\[18F\]MK6240 will be used to measure Tau burden.
Time frame: 5 years
Amyloid burden
\[11C\]PiB will reflect amyloid burden.
Time frame: 5 years
Tracer rate constant
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.
Time frame: 5 years
Associations between imaging modalities and biomarkers.
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.
Time frame: 5 years
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
Measure of cerebrovascular burden
volume of White matter hyperintensities (WMH) on T1 images or T2 images
Time frame: 5 years
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
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
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