ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson (PET/MR-P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01779869
Recruitment Status : Completed
First Posted : January 30, 2013
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Pamela Woodard, MD, Washington University School of Medicine

Brief Summary:

The objective for this pilot study is to develop an optimized, clinically usable myocardial PET-MR perfusion protocol and to determine which of all data potentially available should be acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion imaging, significantly decreasing examination time and patient radiation dose while maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage.

The primary outcome will be comparison of diagnostic accuracy of each combination of imaging to detect clinically significant coronary artery stenosis (≥70% diameter stenosis).


Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Drug: Regadenoson Phase 4

Detailed Description:

Simultaneous acquisition PET-MRI is a new technology that has the potential to significantly impact diagnostic patient care. It combines high signal resolution MRI anatomic imaging and PET biological measurements, with the added benefit of radiation dose reduction in comparison to PET-CT. As the incidence of false positive SPECT-MPI studies secondary to attenuation artifact is relatively high and MRI coverage of the left ventricular myocardium is limited, it is likely that one of the immediate applications of PET-MRI technology is myocardial ischemia assessment.

PET has long been considered the noninvasive reference standard for myocardial perfusion. However, delayed contrast enhanced (DCE) MRI is very sensitive for infarct detection. Indeed, both PET and MR imaging have the potential to provide comprehensive whole heart ischemia and infarct detection.

PET-MR technology, with its ability to obtain simultaneous perfusion information via both PET and MRI, has the potential to obtain multiple, possibly redundant, data sets. On the other hand, it also has the potential to combine the best of both techniques to provide a highly robust examination that is both shorter and of lower radiation dose than the standard myocardial PET perfusion examination. Optimization of a protocol is necessary to develop a comprehensive protocol without redundancy. Because of its single injection capability, regadenoson is ideally suited to a protocol that will assess and employ dual-modality myocardial perfusion data collection.

It is expected that the best candidates for PET-MR myocardial perfusion imaging will likely be a) patients whose body habitus suggests that their SPECT-MPI examination would be limited by attenuation artifact -- women with large breasts and patients (usually men) with abdominal obesity and/or b) patients who may have a smaller region of ischemia that might be missed on an MRI examinations with limited perfusion coverage.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arm Intervention/treatment
Experimental: Single group assignment - imaging
All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.
Drug: Regadenoson
Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging.
Other Name: Lexiscan




Primary Outcome Measures :
  1. Diagnostic Accuracy of Cardiac PET/MRI Examination [ Time Frame: PET/MRI imaging was performed within 10 days after SPECT-MPI examination ]
    The accuracy of the cardiac PET and cardiac MR examination components of the PET/MRI, and the accuracy of the combined PET/MR examination, for ischemic heart disease will be compared to the accuracy of cardiac SPECT in patients who have had ICA as "truth" or the reference standard. To assess the accuracy of an abbreviated PET/MR examination, an additional accuracy analysis was made using only the stress PET perfusion imaging and the MR LGE data sets. The accuracy of this combined data set was also determined with ICA as "truth" or the reference standard. Accuracy is calculated as % difference = (experimental - true) x 100%.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have had a clinically ordered rest/regadenoson single-isotope SPECT-MPI study within 10 days prior to cardiac PET-MRI examination
  • Reversible perfusion abnormalities on SPECT imaging in at least 2 contiguous myocardial segments
  • Patients for whom standard of care coronary ICA is planned

Exclusion Criteria:

  • An clinical event (ie; worsening angina pectoris or myocardial infarction) occuring after the SPECT-MPI and before the cardiac MRI examination
  • Myocardial revascularization occuring after the SPECT-MPI and before the cardiac MRI examination
  • Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, etc.)
  • Renal insufficiency (GFR < 60 mL/min/1.73m2)
  • Allergy or other contraindication to gadolinium-based MR contrast agent
  • Second or third degree atrioventricular (AV) block
  • Active asthma
  • Seizures
  • Current hypotension (<100/60)
  • Current hypertension (>160/90)
  • Pregnancy
  • Breast feeding
  • Use of caffeine, nicotine or over the counter cold medicines within 12 hours of the cardiac PET-MRI examination
  • Use of the medication dipyridamole within 48 hrs of the cardiac PET-MRI examination

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): NCT01779869


Locations
United States, Missouri
Center for Clinical Imaging Research at Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Pamela K Woodard, MD, BA Washington University School of Medicine

Responsible Party: Pamela Woodard, MD, Director of Center for Clinical Imaging Research (CCIR), Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01779869     History of Changes
Other Study ID Numbers: PET/MR-Perfusion
First Posted: January 30, 2013    Key Record Dates
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Analyzed data will be shared with other researchers after publication of manuscript.

Keywords provided by Pamela Woodard, MD, Washington University School of Medicine:
PET MR myocardial perfusion imaging

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs