Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications

NCT02062008 — Not applicable, Terminated, 2 participants, University of California, San Francisco

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Registry	NCT02062008
Status	Terminated - Lack of funding to continue.
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	2 (Actual)
Sponsor	University of California, San Francisco (Other)
Conditions	Cardiac Disease
Interventions	PET-MRI (Device)
Dates	start 2016-12-01, primary completion 2018-02-10, completion 2018-02-10, first posted 2014-02-13, last updated 2021-06-16
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Cardiac patients receiving PET/MR	Other	Device: PET-MRI	PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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%.

+Posted results

Participant flow

Milestone	Cardiac Patients Receiving PET/MR
Started	2
Completed	2
Not completed	0

Outcome results

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. (Primary), Number, quality image: Cardiac Patients Receiving PET/MR 2

Adverse events

Time frame: One year

Arm	Deaths	Serious adverse events	Other adverse events
Cardiac Patients Receiving PET/MR	0/2 (0.0%)	0/2 (0.0%)	0/2 (0.0%)

+Locations (1)

Facility	City	Country	Status
UCSF University of California in San Francisco	San Francisco, California	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2016-12-12)

+Investigators

Karen G Ordovas, MD,MAS, Principal investigator, Assistent Professor

My Notes

Public

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