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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Ischemic Heart Disease
• Intervention / Treatment: Drug: Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cardiac PET scan; 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.

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.; Other Names: Positron emission tomography (PET Scan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Venkatesh L. Murthy, M.D., University of Michigan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: positron emission tomography; FDG; myocardial perfusion imaging; viability; rubidium
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: HUM00080193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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