Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging

University of Michigan

Status and phase: Completed; Early Phase 1

Conditions: Ischemic Heart Disease; Myocardial Infarction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02003456

HUM00080193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cardiac PET scan

Experimental group

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.

Treatment:

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