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临床试验/NCT02003456
NCT02003456已完成早期 1 期

Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging

University of Michigan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Equivalence of Images from Rest Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously

研究概览

简要总结

Positron emission tomography (PET) scans can be used to evaluate whether parts of the heart muscle are alive but receiving inadequate blood supply. This study involves the use of two radiotracers that will measure whether heart muscle cell are alive and quantify the blood supply to the heart muscle.

详细描述

Positron emission tomography (PET) scans can be used to evaluate whether parts of the heart muscle (myocardium) are alive but receiving inadequate blood supply. This information can be helpful in identifying the best course of treatment. This type of study involves the use of two radiotracers: rubidium-82 (to measure blood flow) and 18F-fluorodeoxyglucose or FDG (to measure whether heart muscle cells are alive). Currently, each of these radiotracers is imaged at separate times, several hours apart. The purpose of this study is to evaluate methods that could allow the entire study to be performed at one time.

研究设计

研究类型
Interventional
分配方式
Na
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Patients referred for clinically indicated positron emission tomography (PET) viability assessment with rubidium-82 rest perfusion imaging and 18F-fluorodeoxyglucose (FDG) metabolic imaging.

排除标准

  • Need for stress perfusion imaging
  • Claustrophobia which would prevent positron emission tomography (PET) imaging.
  • Inability to lie flat with arms positioned next to the head for approximately 20 minutes.
  • Clinical instability such as uncontrolled, potentially life threatening arrhythmias or heart failure requiring mechanical support or infusions of inotropic or vasopressor agents.

研究组 & 干预措施

Cardiac PET scan

Experimental

To evaluate methods that could allow the use of two radiotracers(rubidium-82/18F-fluorodeoxyglucose(FDG)and rubidium-82, that are used in cardiac positron emission tomography(PET)imaging scans to be performed at one time instead of the current method which involves being imaged at separate times, several hours apart.

干预措施: Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82 (Drug)

结局指标

主要结局

Equivalence of Images from Rest Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously

时间窗: 2 years

To establish that polar map images from rest rubidium-82 myocardial perfusion imaging performed prior to injection of 18F-fluorodeoxyglucose (FDG) as is routinely performed currently during clinical PET viability studies and rest rubidium-82 myocardial perfusion imaging performed simultaneously with FDG during the second half of an extended FDG imaging session are clinically equivalent.

次要结局

  • Equivalence of Images from FDG PET Obtained Separately versus Simultaneously(2 Years)
  • Equivalence of Quantitative Estimates of Global Myocardial Blood Flow using Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously(2 years)

研究者

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

Venkatesh L. Murthy, M.D., Ph.D.

Principal Investigator

University of Michigan

研究点 (1)

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