Overview

This trial is active, not recruiting.

Conditions ischemic heart disease, myocardial infarction
Treatments cardiac pet w/18f-fluorodeoxyglucose and rubidium-82, pet scan
Phase phase 0
Sponsor University of Michigan
Start date December 2013
End date August 2014
Trial size 30 participants
Trial identifier NCT02003456, HUM00080193

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-equivalence study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(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.
cardiac pet w/18f-fluorodeoxyglucose and rubidium-82 Positron emission tomography (PET Scan)
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.
pet scan

Primary Outcomes

Measure
Equivalence of Images from Rest Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously
time frame: 2 years

Secondary Outcomes

Measure
Equivalence of Quantitative Estimates of Global Myocardial Blood Flow using Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously
time frame: 2 years
Equivalence of Images from FDG PET Obtained Separately versus Simultaneously
time frame: 2 Years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 18 years of age or older 2. 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: 1. Need for stress perfusion imaging 2. Claustrophobia which would prevent positron emission tomography (PET) imaging. 3. Inability to lie flat with arms positioned next to the head for approximately 20 minutes. 4. Clinical instability such as uncontrolled, potentially life threatening arrhythmias or heart failure requiring mechanical support or infusions of inotropic or vasopressor agents. 5. Pregnancy

Additional Information

Official title Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging
Principal investigator Venkatesh L. Murthy, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Michigan.