Back to resultsInitial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging
Primary Purpose
Ischemic Heart Disease, Myocardial Infarction
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82
Sponsored by
About this trial
This is an interventional diagnostic trial for Ischemic Heart Disease focused on measuring positron emission tomography, rubidium, myocardial perfusion imaging, viability, FDG
Eligibility Criteria
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
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac PET scan
Arm Description
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.
Outcomes
Primary Outcome Measures
Equivalence of Images from Rest Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously
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 Outcome Measures
Equivalence of Quantitative Estimates of Global Myocardial Blood Flow using Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously
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.
Equivalence of Images from FDG PET Obtained Separately versus Simultaneously
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.
Full Information
NCT ID
NCT02003456
First Posted
November 4, 2013
Last Updated
February 20, 2017
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02003456
Brief Title
Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging
Official Title
Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Myocardial Infarction
Keywords
positron emission tomography, rubidium, myocardial perfusion imaging, viability, FDG
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac PET scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82
Other Intervention Name(s)
Positron emission tomography (PET Scan)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Equivalence of Images from Rest Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Equivalence of Quantitative Estimates of Global Myocardial Blood Flow using Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously
Description
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.
Time Frame
2 years
Title
Equivalence of Images from FDG PET Obtained Separately versus Simultaneously
Description
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.
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkatesh L. Murthy, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging
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