Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

Not Applicable

Withdrawn

• Conditions: MRI Scans
• Interventions: Drug: Adenosine; Drug: Regadenoson; Drug: O-15 labeled radioactive water; Device: MRI; Device: PET Imaging

• Registration Number: NCT02608944
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-09-30
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Primary Completion: 2019-06-12
• Study Completion: 2019-06-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI perfusion vs. PET Imaging perfusion	PET Imaging	Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging
MRI perfusion vs. PET Imaging perfusion	MRI	Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging
MRI perfusion vs. PET Imaging perfusion	O-15 labeled radioactive water	Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging
MRI perfusion vs. PET Imaging perfusion	Adenosine	Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging
MRI perfusion vs. PET Imaging perfusion	Regadenoson	Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Utah, Radiology Research; 🇺🇸 Salt Lake City, Utah, United States