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Completed

NCT Number: NCT02003456

Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging

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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Pregnancy

Treatment and study plan

Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82

Drug

Study subjects will undergo a Cardiac PET scan that will take approximately 20 minutes to complete. In addition to standard clinical rubidium-82/18F-fluorodeoxyglucose (FDG) PET imaging, during a separate imaging session, participants will be infused with a second dose of the radio-tracer rubidium-82 during FDG imaging scan that will take an additional 10 to 15 minutes to complete.

Other names: Positron emission tomography (PET Scan)

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Equivalence of Quantitative Estimates of Global Myocardial Blood Flow using Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously

    Time frame: 2 years

    To establish that quantitative estimates of global myocardial blood flow at rest determined from 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.

  2. Equivalence of Images from FDG PET Obtained Separately versus Simultaneously

    Time frame: 2 Years

    To establish that FDG PET images obtained prior to injection of rubidium-82 and those obtained simultaneously with FDG during the second half of an extended FDG imaging session are clinically equivalent.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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