F 18 T807 PET (Positron Emission Tomograph )Scan for HIV Infected & Uninfected
2020年9月17日 更新者：Tammie L. S. Benzinger, MD, PhD
F 18 T807 Tau PET Imaging of Older (>= 40 Years Old) HIV Infected (HIV+) and HIV Uninfected (HIV-) Individuals (IND 123119, Protocol G)
This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807, also known as T807, also known as 7-(6-fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole), a novel tau imaging compound, in older HIV+ individuals with and without HAND and matched HIV uninfected (HIV-) controls.
The primary goal is to develop this highly promising tau imaging technique as an biomarker of cognitive decline in HIV+ individuals.
The investigators will obtain preliminary data that will support the possibility of detecting early brain pathological changes due to HIV.
Data generated from this study will be used for submission of National Institutes of Health (NIH) grants comparing tau deposition in HAND compared to other neurodegenerative disorders.
It is hypothesized that specific topographies will help distinguish these neurodegenerative disorders in older individuals.
研究概览
详细说明
This protocol will demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV- controls.
It will also demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with MND will have greater tau cortical deposition compared to ANI individuals.
The investigtors hypothesize that in vivo tau imaging will ultimately:
- Demonstrate the presence of tau fibrils in older HIV+ patients with HIV associated neurocognitive disorders (HAND) compared to cognitively normal HIV+ individuals and HIV- controls.
- Demonstrate that the phenoconversion from cognitively normal (CN) status to HAND will be closely correlated with neocortical F 18 T807 uptake. In particular, HIV+ patients with MND will have greater tau cortical deposition compared to ANI individuals.
研究类型
观察性的
注册 (实际的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
40 HIV+ and 40 HIV- participants will be enrolled.
描述
Inclusion Criteria:
- Male or female participants, ≥ 40 years of age.
- Testing for HIV status. If positive will be included in the HIV+ group and if negative will be included in the HIV- group.
- Females without documented history of menopause or hysterectomy will undergo a urine pregnancy test 24 hours prior to F 18 T807 drug administration.
Exclusion Criteria:
- Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
- Has hypersensitivity to F 18 T807 or any of its excipients.
- Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- Severe claustrophobia.
- Currently pregnant or breast-feeding.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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F 18 T807
Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
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参与者将接受约 6.5-10mCi (240-370MBq) F 18 T807 的单次静脉推注。
对于无法耐受完整检查的人，参与者将接受单次静脉推注约 6.5-10mCi (240-370MBq) F 18 T807。
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Perform human in vivo tau imaging using F 18 T807 in 30 older (≥ 40 years old) HIV+ participants and 30 HIV- controls.
大体时间：5 years
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5 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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: Correlate regional quantitative T807 binding potentials (BPs) with cognitive impairment, as documented by neuropsychological performance tests, in HIV+ and HIV- individuals.
大体时间：5 years
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5 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tammie Benzinger, MD, PhD、Washington University School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年5月3日
初级完成 (实际的)
2018年5月23日
研究完成 (实际的)
2018年5月23日
研究注册日期
首次提交
2016年5月3日
首先提交符合 QC 标准的
2017年9月8日
首次发布 (实际的)
2017年9月12日
研究记录更新
最后更新发布 (实际的)
2020年9月22日
上次提交的符合 QC 标准的更新
2020年9月17日
最后验证
2020年9月1日
更多信息
与本研究相关的术语
其他研究编号
- IND 123119 Protocol G
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
As part of this study, we are obtaining data from the participant.
We would like to use this data' for studies going on right now as well as studies that are conducted in the future.
These studies may provide additional information that will be helpful in understanding cognitive impairment, or other diseases or conditions, including research to develop investigational tests, treatments, drugs or devices that are not yet approved by the U.S. Food and Drug Administration.
It is unlikely that what we learn from these studies will have a direct benefit to the participant.
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
F 18 T807的临床试验
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Washington University School of Medicine邀请报名
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Tammie L. S. Benzinger, MD, PhD完全的老年痴呆症 | Progressive Posterior Cortical Dysfunction (PPCD)美国
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Tammie L. S. Benzinger, MD, PhD完全的