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

This study is currently recruiting participants.
Verified April 2013 by Washington University School of Medicine
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: April 9, 2013
Last verified: April 2013

January 23, 2013
April 9, 2013
January 2013
January 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01779869 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Ischemic Heart Disease
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
Experimental: Single group assignment - imaging
All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.
Intervention: Drug: Regadenoson
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Donna S Lesniak, RN, CCRC 314-747-3875 lesniakd@mir.wustl.edu
Contact: Deborah A DeLano, RN,CCRC,MHS 314-747-3876 delanod@mir.wustl.edu
United States
 
NCT01779869
PET/MR-Perfusion
No
Pamela Woodard, MD, Washington University School of Medicine
Washington University School of Medicine
Astellas Pharma US, Inc.
Principal Investigator: Pamela K Woodard, MD, BA Washington University School of Medicine
Washington University School of Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP