Trial Outcomes & Findings for Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson (NCT NCT01779869)

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

PET/MRI imaging was performed within 10 days after SPECT-MPI examination

Results posted on

2018-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Decision	2

Baseline Characteristics

Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Group Assignment - Imaging n=16 Participants 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.
Age, Continuous	55 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Positive cardiac SPECT stress test (2 contiguous segments)	16 Participants n=5 Participants
Scheduled to undergo ICA	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: PET/MRI imaging was performed within 10 days after SPECT-MPI examination

Population: Patients who completed the full PET-MR myocardial perfusion 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%.

Outcome measures

Outcome measures
Measure	Single Group Assignment - Imaging n=16 Participants 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.
Diagnostic Accuracy of Cardiac PET/MRI Examination Abbreviated PET/MR	64 percentage Interval 35.0 to 87.0
Diagnostic Accuracy of Cardiac PET/MRI Examination SPECT Accuracy	50 percentage Interval 23.0 to 77.0
Diagnostic Accuracy of Cardiac PET/MRI Examination MR Accuracy	64 percentage Interval 35.0 to 87.0
Diagnostic Accuracy of Cardiac PET/MRI Examination PET Accuracy	61 percentage Interval 29.0 to 82.0
Diagnostic Accuracy of Cardiac PET/MRI Examination Combined PET/MR Accuracy	64 percentage Interval 35.0 to 87.0

Adverse Events

Single Group Assignment - Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela K. Woodard, M.D.

Washington University School of Medicine

Phone: 314-362-7130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place