Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

MRI Scans Clinical Trial

Official title:

Comparison of New MRI Methods for Quantitative Assessment of Myocardial Perfusion With Quantitative PET Perfusion Imaging

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02608944
• Other study ID #: IRB 58133
• Status: Withdrawn
• Phase: N/A
• Start date: September 30, 2012
• Est. completion date: June 12, 2019

Study information

• Verified date: September 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 12, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• MRI Scans

Intervention

Drug:
• 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

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Utah, Radiology Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.