Validation of Combined PET-MR Quantitative Parameters for Cardiac Applications

May 20, 2021 updated by: University of California, San Francisco
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • UCSF University of California in San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cardiac patients receiving PET/MR
PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.
Device: PET-MRI
PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 hours
Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Karen G Ordovas, MD,MAS, Assistent Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

February 10, 2018

Study Completion (Actual)

February 10, 2018

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Combined PET-MRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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