Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging

Myocardial Infarction Clinical Trial

Official title:

Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003456
• Other study ID #: HUM00080193
• Status: Completed
• Phase: Early Phase 1
• First received: November 4, 2013
• Last updated: February 20, 2017
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82
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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 Years