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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Pamela Woodard, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01779869
First received: January 23, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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). The secondary outcome will be comparison of confidence for presence of disease among data sets.


Condition Intervention Phase
Ischemic Heart Disease
Drug: Regadenoson
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Diagnostic accuracy of cardiac PET-MRI examination [ Time Frame: Up to 10 days after SPECT-MPI examination ] [ Designated as safety issue: No ]
    The primary outcome will be comparison of diagnostic accuracy of each combination of imaging to detect clinically significant coronary artery stenosis (≥70% diameter stenosis).


Secondary Outcome Measures:
  • Reader confidence for disease presence [ Time Frame: Up to 10 days after SPECT-MPI examination ] [ Designated as safety issue: No ]
    Secondary outcome will be comparison of confidence for presence of disease among data sets.


Estimated Enrollment: 15
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779869

Locations
United States, Missouri
Center for Clinical Imaging Research at Washington University School of Medicine
St. 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
  More Information

No publications provided

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
Study First Received: January 23, 2013
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
PET MR myocardial perfusion imaging

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

ClinicalTrials.gov processed this record on October 23, 2014