Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/17/2018 |
| Start Date: | January 2013 |
| End Date: | June 2015 |
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).
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).
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.
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.
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
We found this trial at
1
site
Saint Louis, Missouri 63110
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