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Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

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ClinicalTrials.gov Identifier: NCT02608944
Recruitment Status : Withdrawn (MRI perfusion techniques development took longer than expected.)
First Posted : November 20, 2015
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Edward DiBella, University of Utah

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE September 30, 2012
Actual Primary Completion Date June 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Myocardial perfusion values from MRI [ Time Frame: 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.
  • Myocardial perfusion values from PET [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging
Official Title  ICMJE Comparison of New MRI Methods for Quantitative Assessment of Myocardial Perfusion With Quantitative PET Perfusion Imaging
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE MRI Scans
Intervention  ICMJE
  • 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 Name: 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 Name: 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 Name: Positron Emission Tomography Imaging
Study Arms  ICMJE Experimental: MRI perfusion vs. PET Imaging perfusion
Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging
Interventions:
  • Drug: Adenosine
  • Drug: Regadenoson
  • Drug: O-15 labeled radioactive water
  • Device: MRI
  • Device: PET Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 1, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2015)
20
Actual Study Completion Date  ICMJE June 12, 2019
Actual Primary Completion Date June 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608944
Other Study ID Numbers  ICMJE IRB 58133
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edward DiBella, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward DiBella, Ph.D. University of Utah
PRS Account University of Utah
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP