Exploring the Utility of [18F]3F4AP for Demyelination Imaging
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Distribution volume ratio (DVR)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Multiple Sclerosis (MS)
n = 15 - up to three PET scanning sessions.
干预措施: [ 18F]3F4AP (Drug)
Multiple Sclerosis (MS)
n = 15 - up to three PET scanning sessions.
干预措施: [18F]MK6240 (Drug)
Multiple Sclerosis (MS)
n = 15 - up to three PET scanning sessions.
干预措施: [11C]PIB (Drug)
Spinal Cord Injury (SCI)
n = 15 - up to three PET scanning sessions.
干预措施: [ 18F]3F4AP (Drug)
Spinal Cord Injury (SCI)
n = 15 - up to three PET scanning sessions.
干预措施: [18F]MK6240 (Drug)
Spinal Cord Injury (SCI)
n = 15 - up to three PET scanning sessions.
干预措施: [11C]PIB (Drug)
Spinal radiculopathy (SR)
n = 15 - up to three PET scanning sessions.
干预措施: [ 18F]3F4AP (Drug)
Spinal radiculopathy (SR)
n = 15 - up to three PET scanning sessions.
干预措施: [18F]MK6240 (Drug)
Spinal radiculopathy (SR)
n = 15 - up to three PET scanning sessions.
干预措施: [11C]PIB (Drug)
Alzheimer's Disease (AD)
n = 15 - up to three PET scanning sessions.
干预措施: [18F]MK6240 (Drug)
Alzheimer's Disease (AD)
n = 15 - up to three PET scanning sessions.
干预措施: [11C]PIB (Drug)
Mild Cognitive Impairment (MCI)
n = 15 - up to three PET scanning sessions.
干预措施: [ 18F]3F4AP (Drug)
Mild Cognitive Impairment (MCI)
n = 15 - up to three PET scanning sessions.
干预措施: [18F]MK6240 (Drug)
Mild Cognitive Impairment (MCI)
n = 15 - up to three PET scanning sessions.
干预措施: [11C]PIB (Drug)
Healthy Control
n = 30 - up to three PET scanning sessions.
干预措施: [ 18F]3F4AP (Drug)
Healthy Control
n = 30 - up to three PET scanning sessions.
干预措施: [18F]MK6240 (Drug)
Healthy Control
n = 30 - up to three PET scanning sessions.
干预措施: [11C]PIB (Drug)
Alzheimer's Disease (AD)
n = 15 - up to three PET scanning sessions.
干预措施: [ 18F]3F4AP (Drug)
结局指标
主要结局
Distribution volume ratio (DVR)
时间窗: 5 years
PET images acquired with \[18F\]3F4AP, \[18F\]MK6240 and \[11C\]PiB, will measure the tracers distribution volume ratio (DVR).
Binding potential (BPND)
时间窗: 5 years
PET images acquired with \[18F\]3F4AP, \[18F\]MK6240 and \[11C\]PiB, will measure the tracers binding potential (BPND).
Tracers volume of distribution (VT)
时间窗: 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).
Demyelination
时间窗: 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.
Tau burden
时间窗: 5 years
\[18F\]MK6240 will be used to measure Tau burden.
Amyloid burden
时间窗: 5 years
\[11C\]PiB will reflect amyloid burden.
Tracer rate constant
时间窗: 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.
Associations between imaging modalities and biomarkers.
时间窗: 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.
次要结局
- Measure of brain atrophy(5 years)
- Measure of cerebrovascular burden(5 years)
- Measure of White matter lesions (WML)(5 years)
- MR/MRSI images(5 years)
研究者
Georges El Fakhri
Professor of Radiology and Biomedical Imaging and of Biomedical Informatics & Data Science
Yale University