Initial Human Validation of Simultaneous Dual-Tracer Cardiac PET Imaging

NCT02003456 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HUM00080193
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Myocardial Infarction

Keywords

positron emission tomography; rubidium; myocardial perfusion imaging; viability; FDG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Equivalence of Quantitative Estimates of Global Myocardial Blood Flow using Rubidium-82 Perfusion PET Obtained Separately versus Simultaneously

  2 years

• Equivalence of Images from FDG PET Obtained Separately versus Simultaneously

  2 Years

Study Arms (1)

Cardiac PET scan

EXPERIMENTAL

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

Interventions

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

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.

Also known as: Positron emission tomography (PET Scan)

Cardiac PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia; Myocardial Infarction

Interventions

Rubidium-82; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Venkatesh L. Murthy, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: December 6, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)