Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging
NCT ID: NCT02608944
Last Updated: 2020-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-09-30
2019-06-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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MRI perfusion vs. PET Imaging perfusion
Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging
Adenosine
Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
Regadenoson
Regadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
O-15 labeled radioactive water
O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
MRI
Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
PET Imaging
Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day.
Interventions
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Adenosine
Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
Regadenoson
Regadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
O-15 labeled radioactive water
O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
MRI
Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
PET Imaging
Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both healthy and subjects with cardiac disease (including atrial fibrillation but not required) will be recruited.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Utah
OTHER
Responsible Party
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Edward DiBella
Ph.D.
Principal Investigators
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Edward DiBella, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah, Radiology Research
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB 58133
Identifier Type: -
Identifier Source: org_study_id
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