Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

Sponsor
University of Utah (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02608944
Collaborator
(none)
0
1
1
80.4
0

Study Details

Study Description

Brief Summary

This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with quantitative PET imaging.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

This project aims to determine the validity of quantitative MRI perfusion methods by comparison with quantitative PET imaging. First pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson. After custom reconstruction and post-processing the data will be fit to a compartment model and quantitative perfusion and MPR values obtained.

On another day, the subjects will have quantitative PET imaging with O-15 labeled radioactive water. This will be done at rest and hyperemia caused by either adenosine or regadenoson. A low dose CT scan will be acquired to perform attenuation correction of the PET images. The images will be reconstructed and processed as reported in the literature to provide reference standard perfusion and MPR values. These values will be compared with those obtained by MRI.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Comparison of New MRI Methods for Quantitative Assessment of Myocardial Perfusion With Quantitative PET Perfusion Imaging
Actual Study Start Date :
Sep 30, 2012
Actual Primary Completion Date :
Jun 12, 2019
Actual Study Completion Date :
Jun 12, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: MRI perfusion vs. PET Imaging perfusion

Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging

Drug: Adenosine
Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
Other Names:
  • Adenoscan
  • Adenocard
  • Drug: Regadenoson
    Regadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
    Other Names:
  • Lexiscan
  • Drug: O-15 labeled radioactive water
    O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
    Other Names:
  • O-15 water
  • Device: MRI
    Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson

    Device: PET Imaging
    Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day.
    Other Names:
  • Positron Emission Tomography Imaging
  • Outcome Measures

    Primary Outcome Measures

    1. Myocardial perfusion values from MRI [The scan will take ~1-2 hours. The MRI will be done within 2 months of the PET scan.]

      Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic MRI data. The perfusion values will be compared to PET data to determine how similar the values are.

    2. Myocardial perfusion values from PET [The scan will take ~1-2 hours. The PET scan will be done within 2 months of the MRI.]

      Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic PET data. The perfusion values will be compared to MRI data to determine how similar the values are.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • Inclusion Criteria:

    • All participants will be over the age of 18 and able to provide consent

    • Both healthy and subjects with cardiac disease (including atrial fibrillation but not required) will be recruited.

    • Exclusion Criteria:

    • Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.

    • Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).

    • Patients with contraindication to MRI (pacemaker, metal implants, or certain types of heart valves),

    • pregnant patients, minors, mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).

    • Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR<30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents. This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.

    • Patients with a known allergy or contraindication to Adenosine and/or Regadenoson will be excluded from stress (hyperemia) cohorts.

    • All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah, Radiology Research Salt Lake City Utah United States 84108

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Edward DiBella, Ph.D., University of Utah

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward DiBella, Ph.D., University of Utah
    ClinicalTrials.gov Identifier:
    NCT02608944
    Other Study ID Numbers:
    • IRB 58133
    First Posted:
    Nov 20, 2015
    Last Update Posted:
    Sep 14, 2020
    Last Verified:
    Sep 1, 2020
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2020