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临床试验/NCT04710550
NCT04710550进行中(未招募)1 期

Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年1月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
8
试验地点
1
主要终点
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

研究概览

简要总结

The overall objective is to obtain an initial assessment of the value of using [18F]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD):

  • Aim 1) Assess the safety of [18F]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of [18F]3F4AP will result in no changes in vitals or other adverse events.
  • Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits.
  • Aim 3) Assess the pharmacokinetics of a bolus infusion of [18F]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of [18F]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas.
  • Aim 4) Correlate MR images with [18F]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all.
  • Aim 5) Correlate [18F]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).

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

入选标准

  • Subjects are 18 years of age and older, except AD subjects who are 60 to 90 years of age.

排除标准

  • A subject will not be eligible for inclusion in this study if any of the exclusion criteria for PET/CT or MRI studies applies. A negative STAT quantitative serum hCG pregnancy test is required on the day of the PET/CT scan before female subjects of childbearing potential can participate. Any woman of childbearing potential, who is seeking to become pregnant, is breastfeeding, or who suspects she may be pregnant will not be enrolled in the study.

研究组 & 干预措施

Safety/Dosimetry Cohort

Experimental

干预措施: F18-3F4AP (Drug)

Traumatic Brain Injury

Experimental

干预措施: F18-3F4AP (Drug)

AD/MCI

Experimental

干预措施: F18-3F4AP (Drug)

Healthy Controls

Active Comparator

干预措施: F18-3F4AP (Drug)

结局指标

主要结局

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

时间窗: 5 years

Determine number of participants with treatment-related adverse events as assessed by CTCAE v4.0

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc D.Normandin, Ph.D

Associate Professor

Massachusetts General Hospital

研究点 (1)

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