Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications

NCT ID: NCT02062008

Last Updated: 2021-06-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-02-10

Brief Summary

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The purpose of this study is to understand how simultaneous PET/MR acquisition can provide novel qualitative and quantitative biomarkers to guide clinical intervention and predict prognosis of patients with cardiovascular disease.

Detailed Description

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* To compare regional myocardial uptake of FDG on images obtained on a standard PET camera with the new PET/MR camera, in patients with coronary artery disease.
* To compare viability maps obtained with cardiac MR images and FDG-PET for delineation of myocardial infarct core and border zone, in patients with coronary artery disease.
* To correlate MRI myocardial strain with relative myocardial FDG uptake in patients with a previous myocardial infarction.
* To interrogate if simultaneous acquisition of cardiac PET and viability cardiac MR differ from acquisitions obtained independently, with special focus on attenuation correction methods
* To combined MRI scar map with FDG-PET uptake in patients with cardiac sarcoidosis and myocarditis.
* To correlate morphologic characteristics of atherosclerotic disease in the thoracic and abdominal aorta with FDG uptake and ferumoxytol enhancement, as a marker of inflammation.
* To evaluate cardiac strain and myocardial scar burden in obese patients with and without diabetes.

Conditions

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Cardiac Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cardiac patients receiving PET/MR

PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

Group Type OTHER

PET-MRI

Intervention Type DEVICE

PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

Interventions

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PET-MRI

PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with ischemic and non-ischemic cardiac disease referred for cardiac PET for viability imaging.

Exclusion Criteria

* Contraindications for MRI, including cardiac pacemaker, claustrophobia, retained metallic foreign body, cochlear implant, Aneurysm clip in the brain, pregnancy and eGFR less than 45%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen G Ordovas, MD,MAS

Role: PRINCIPAL_INVESTIGATOR

Assistent Professor

Locations

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UCSF University of California in San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Combined PET-MRI

Identifier Type: -

Identifier Source: org_study_id

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