Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications

Cardiac Disease Clinical Trial

Official title:

Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02062008
• Other study ID #: Combined PET-MRI
• Status: Terminated
• Phase: N/A
• Start date: December 2016
• Est. completion date: February 10, 2018

Study information

• Verified date: May 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 10, 2018
• Est. primary completion date: February 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
United States	UCSF University of California in San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.	2 hours