Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications

Not Applicable

Terminated

• Conditions: Cardiac Disease
• Interventions: Device: PET-MRI

• Registration Number: NCT02062008
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

* 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.

Study Timeline

• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Study Start: 2016-12
• Primary Completion: 2018-02-10
• Study Completion: 2018-02-10
• Status Verified: 2021-05
• Results First Submitted: 2021-05-20
• Results First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Results First Posted: 2021-06-16
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

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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%.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac patients receiving PET/MR	PET-MRI	PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

Primary Outcome Measures

Name	Time	Method
Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease.	2 hours	Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.

Trial Locations

Locations (1)

UCSF University of California in San Francisco; 🇺🇸 San Francisco, California, United States