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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group assignment - imaging | Experimental | All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Cardiac PET/MRI 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%. | PET/MRI imaging was performed within 10 days after SPECT-MPI examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela K Woodard, MD, BA | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Imaging Research at Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Analyzed data will be shared with other researchers after publication of manuscript.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Group Assignment - Imaging | All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Individuals who had undergone a clinical SPECT stress test and were found to have ischemia in at least 2 continuous segments (based on a 17-segment model), and had been scheduled to undergo ICA for diagnostic and/or therapeutic considerations
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Group Assignment - Imaging | All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnostic Accuracy of Cardiac PET/MRI 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%. | Patients who completed the full PET-MR myocardial perfusion examination | Posted | Number | 95% Confidence Interval | percentage | PET/MRI imaging was performed within 10 days after SPECT-MPI examination |
|
24 hours after imaging
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Group Assignment - Imaging | All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela K. Woodard, M.D. | Washington University School of Medicine | 314-362-7130 | woodardp@wustl.edu |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Positive cardiac SPECT stress test (2 contiguous segments) | Count of Participants | Participants | No |
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| Scheduled to undergo ICA | Count of Participants | Participants |
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All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.
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.
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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