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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Recruitment Status : Withdrawn (MRI perfusion techniques development took longer than expected.)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

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
MRI Scans Drug: Adenosine Drug: Regadenoson Drug: O-15 labeled radioactive water Device: MRI Device: PET Imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 30, 2012
Actual Primary Completion Date : June 12, 2019
Actual Study Completion Date : June 12, 2019

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608944


Locations
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United States, Utah
University of Utah, Radiology Research
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Edward DiBella, Ph.D. University of Utah
  Study Documents (Full-Text)

Documents provided by Edward DiBella, University of Utah:
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Responsible Party: Edward DiBella, Ph.D., University of Utah
ClinicalTrials.gov Identifier: NCT02608944    
Other Study ID Numbers: IRB 58133
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Adenosine
Regadenoson
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adenosine A2 Receptor Agonists