Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

NCT02608944 | Withdrawn

• 1 other identifier: IRB 58133
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

MRI Scans

Outcome Measures

Primary Outcomes (2)

• Myocardial perfusion values from MRI

  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.

  The scan will take ~1-2 hours. The MRI will be done within 2 months of the PET scan.

• Myocardial perfusion values from PET

  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.

  The scan will take ~1-2 hours. The PET scan will be done within 2 months of the MRI.

Study Arms (1)

MRI perfusion vs. PET Imaging perfusion

EXPERIMENTAL

Adenosine Regadenoson O-15 labeled radioactive water MRI PET Imaging

Drug: Adenosine; Drug: Regadenoson; Drug: O-15 labeled radioactive water; Device: MRI; Device: PET Imaging

Interventions

Adenosine DRUG

Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion

Also known as: Adenoscan, Adenocard

MRI perfusion vs. PET Imaging perfusion

Regadenoson DRUG

Regadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.

Also known as: Lexiscan

MRI perfusion vs. PET Imaging perfusion

O-15 labeled radioactive water DRUG

O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging

Also known as: O-15 water

MRI perfusion vs. PET Imaging perfusion

MRI DEVICE

Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson

MRI perfusion vs. PET Imaging perfusion

PET Imaging DEVICE

Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day.

Also known as: Positron Emission Tomography Imaging

MRI perfusion vs. PET Imaging perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah, Radiology Research

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Interventions

Adenosine; regadenoson; Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Edward DiBella, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 20, 2015
• Study Start: September 30, 2012
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

US (1)