Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging

Early Phase 1

Completed

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

• Registration Number: NCT02003456
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2013-11-04
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac PET scan	Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82	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.

Primary Outcome Measures

Name	Time	Method
Equivalence of Images from Rest Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously	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 Outcome Measures

Name	Time	Method
Equivalence of Images from FDG PET Obtained Separately versus Simultaneously	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.
Equivalence of Quantitative Estimates of Global Myocardial Blood Flow using Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States