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Trial record 66 of 95 for:    gadobenate dimeglumine

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

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ClinicalTrials.gov Identifier: NCT01779869
Recruitment Status : Completed
First Posted : January 30, 2013
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Pamela Woodard, MD, Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Ischemic Heart Disease
Intervention Drug: Regadenoson
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Group Assignment - Imaging
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Physician Decision             2
Arm/Group Title Single Group Assignment - Imaging
Hide Arm/Group Description

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 Number of Baseline Participants 16
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
55  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female 9
Male 7
Positive cardiac SPECT stress test (2 contiguous segments)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
16
Scheduled to undergo ICA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
16
 100.0%
1.Primary Outcome
Title Diagnostic Accuracy of Cardiac PET/MRI Examination
Hide Description 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%.
Time Frame PET/MRI imaging was performed within 10 days after SPECT-MPI examination
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the full PET-MR myocardial perfusion examination
Arm/Group Title Single Group Assignment - Imaging
Hide Arm/Group Description:

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 Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
SPECT Accuracy
50
(23 to 77)
MR Accuracy
64
(35 to 87)
PET Accuracy
61
(29 to 82)
Combined PET/MR Accuracy
64
(35 to 87)
Abbreviated PET/MR
64
(35 to 87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Group Assignment - Imaging
Comments Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value < 0.05 was considered significant.
Type of Statistical Test Superiority
Comments Accuracy was assessed compared to an imaging reference standard.
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 24 hours after imaging
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Group Assignment - Imaging
Hide Arm/Group Description

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.

All-Cause Mortality
Single Group Assignment - Imaging
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Group Assignment - Imaging
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Group Assignment - Imaging
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Pamela K. Woodard, M.D.
Organization: Washington University School of Medicine
Phone: 314-362-7130
Responsible Party: Pamela Woodard, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01779869     History of Changes
Other Study ID Numbers: PET/MR-Perfusion
First Submitted: January 23, 2013
First Posted: January 30, 2013
Results First Submitted: January 21, 2018
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018