Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01347710
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Interventions Drug: Flurpiridaz F18
Drug: 99mTechnicium (sestamibi or tetrofosmin)
Enrollment 795
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flurpiridaz F 18
Hide Arm/Group Description Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Period Title: Overall Study
Started 795
Completed 764
Not Completed 31
Reason Not Completed
Withdrawal by Subject             2
Adverse Event             4
Angio or SPECT not completed             18
issue with vitals prior to dosing             1
Lost to Follow-up             1
Physician Decision             2
Other             3
Arm/Group Title Flurpiridaz F 18
Hide Arm/Group Description Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Overall Number of Baseline Participants 795
Hide Baseline Analysis Population Description
Safety population, received at least one dose of flurpiridaz F 18
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 795 participants
<=18 years
0
   0.0%
Between 18 and 65 years
458
  57.6%
>=65 years
337
  42.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 795 participants
Female
249
  31.3%
Male
546
  68.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 795 participants
Hispanic or Latino
43
   5.4%
Not Hispanic or Latino
708
  89.1%
Unknown or Not Reported
44
   5.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 795 participants
American Indian or Alaska Native
2
   0.3%
Asian
8
   1.0%
Native Hawaiian or Other Pacific Islander
4
   0.5%
Black or African American
105
  13.2%
White
652
  82.0%
More than one race
0
   0.0%
Unknown or Not Reported
24
   3.0%
1.Primary Outcome
Title Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
Hide Description Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:

Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of true positive cases
PET MPI sensitivity
.719
(.670 to .763)
SPECT MPI Sensitivity
.537
(.485 to .588)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule
Method McNemar
Comments Two-sided McNemar's (chi-squared) test superiority
2.Primary Outcome
Title Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
Hide Description Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
all safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18
Hide Arm/Group Description:

Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of true negatives
PET MPI Specificity
.762
(.718 to .801)
SPECT MPI Specificity
.868
(.832 to .898)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study protocol number BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value .945
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI
Method Z Test
Comments one-sided z test for non-inferiority for specificity
3.Secondary Outcome
Title Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Hide Description

Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard

I

Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:

Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of true postives
PET sensitivity pharmacologic stress
0.736
(.679 to .785)
SPECT sensitivity pharmacologic stress
0.533
(.472 to .592)
PET sensitivity in females
0.644
(.517 to .754)
SPECT sensitivity in females
0.356
(.246 to .483)
PET sensitivity BMI >/=30
0.722
(.653 to .782)
SPECT sensitivity BMI >/=30
0.533
(.461 to .605)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress
Method McNemar
Comments Two-sided McNemar's (chi-squared) test superiority
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females
Method McNemar
Comments p-Value based on two-sided McNemar's (Chi-squared) test superiority
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI >/=30
Method McNemar
Comments p-Value based on two-sided McNemar's (Chi-squared) test superiority
4.Secondary Outcome
Title Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Hide Description Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:

Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of true negatives
PET MPI specificity pharmacological stress
.773
(.720 to .819)
SPECT MPI specificity pharmacological stress
.875
(.831 to .909)
PET MPI specificity females
.795
(.730 to .848)
SPECT MPI specificity females
.869
(.812 to .911)
PET MPI specificity BMI >/=30
.777
(.719 to .826)
SPECT MPI specificity BMI >/=30
.850
(.798 to .89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value 0.891
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress
Method Z test
Comments z test for non inferiority for specificity
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value .546
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients
Method z test
Comments z test for non-inferiority for specificity
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value .538
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI >/=30
Method z test
Comments z test for non-inferiority for specificity
5.Secondary Outcome
Title Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
Hide Description Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 Flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F 18
Hide Arm/Group Description:
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of true positives
PET sensitivity LAD
.495
(.430 to .561)
SPECT sensitivity LAD
.333
(.275 to .398)
PET sensitivity LCX
.398
(.331 to .469)
SPECT sensitivity LCX
.251
(.195 to .317)
PET sensitivity RCA
.596
(.528 to .661)
SPECT sensitivity RCA
.476
(.409 to .544)
PET sensitivity Non-LAD
.627
(.568 to .682)
SPECT sensitivity Non-LAD
.464
(.406 to .523)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD
Method McNemar
Comments Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX
Method McNemar
Comments p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA
Method McNemar
Comments p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD
Method McNemar
Comments p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD
6.Secondary Outcome
Title Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
Hide Description Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F 18
Hide Arm/Group Description:
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of true negatives
PET specificity LAD
.867
(.835 to .893)
SPECT specificity LAD
.932
(.908 to .951)
PET specificity LCX
.904
(.877 to .926)
SPECT specificity LCX
.970
(.952 to .981)
PET specificity RCA
.845
(.812 to .873)
SPECT specificity RCA
.912
(.886 to .933)
PET specificity Non-LAD
.814
(.777 to .846)
SPECT specificity Non-LAD
.923
(.895 to .943)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value .379
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD
Method z Test
Comments z test for non-inferiority for specificity; LAD
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value .358
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX
Method Z Test
Comments z test for non-inferiority for specificity; LCX
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value .442
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA
Method z Test
Comments z test for non-inferiority for specificity; RCA
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value .984
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD
Method z Test
Comments z test for non-inferiority for specificity; non-LAD
7.Secondary Outcome
Title Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Hide Description Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:

Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of true positives
PET MPI sensitivity; multivessel disease
.410
(.340 to .484)
SPECT MPI sensitivity; multivessel disease
.275
(.215 to .345)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease
Method McNemar
Comments p-Value based on two-sided McNemar's (Chi squared) test superiority
8.Secondary Outcome
Title Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Hide Description Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:

Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of true negatives
PET MPI specificity; multivessel disease
.882
(.853 to .906)
SPECT MPI specificity; multivessel disease
.964
(.945 to .976)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value 0.827
Comments p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease
Method z test
Comments p-Value based on one-sided z test for non-inferiority
9.Secondary Outcome
Title Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good
Hide Description Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of true positives
PET MPI sensitivity; image quality excellent/good
.711
(.658 to .759)
SPECT MPI sensitivity image quality excellent/good
.539
(.483 to .594)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good
Method McNemar
Comments p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity
10.Secondary Outcome
Title Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good
Hide Description Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:

Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of true negatives
PET MPI specificity; image quality excellent/good
.769
(.721 to .811)
SPECT MPI specificity image quality excellent/good
.880
(.841 to .911)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%
Statistical Test of Hypothesis P-Value 0.954
Comments p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good
Method z Test
Comments p-Value based on on-sided z test for non-inferiority for specificity
11.Secondary Outcome
Title Image Quality of Rest and Stress (PET vs SPECT).
Hide Description Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F18 PET MPI
Hide Arm/Group Description:

Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Overall Number of Participants Analyzed 755
Measure Type: Number
Unit of Measure: percent of images
Rest imaging quality PET MPI; excellent/good .891
Rest image quality SPECT MPI; excellent/good .739
Stress image quality PET MPI; excellent/good .976
Stress image quality SPECT MPI; excellent/good .869
Rest image quality PET MPI; fair/poor .109
Rest image quality SPECT MPI; fair/poor .261
stress image quality PET MPI; fair/poor .024
Stress image quality SPECT MPI; fair/poor .131
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F18 PET MPI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
12.Secondary Outcome
Title Diagnostic Certainty in PET MPI and SPECT MPI
Hide Description Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
Arm/Group Title Flurpiridaz F 18
Hide Arm/Group Description:
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Overall Number of Participants Analyzed 755
Measure Type: Number
Unit of Measure: proportion of patients
PET definitely normal/abnormal 0.862
PET probably/equivocal 0.138
SPECT definitely normal/abnormal 0.799
SPECT probably/equivocal 0.201
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurpiridaz F 18
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method McNemar
Comments p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT
Time Frame Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Adverse Event Reporting Description Affected represents patients with at least one serious adverse event and/or adverse event
 
Arm/Group Title Flurpiridaz F 18
Hide Arm/Group Description Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
All-Cause Mortality
Flurpiridaz F 18
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Flurpiridaz F 18
Affected / at Risk (%) # Events
Total   20/795 (2.52%)    
Cardiac disorders   
Angina Pectoris  1  6/795 (0.75%)  6
Atrial Flutter  1  1/795 (0.13%)  1
Cardiac Failure Congestive  1  1/795 (0.13%)  1
Cardiogenic Shock  1  1/795 (0.13%)  1
Ventricular Tachycardia  1  2/795 (0.25%)  2
Gastrointestinal disorders   
Inguinal Hernia  1  1/795 (0.13%)  1
General disorders   
Catheter Site Haemorrhage  1  1/795 (0.13%)  1
Non-Cardiac Chest Pain  1  1/795 (0.13%)  1
Infections and infestations   
Pneumonia  1  1/795 (0.13%)  1
Metabolism and nutrition disorders   
Hypoglycaemia  1  1/795 (0.13%)  1
Nervous system disorders   
Dizziness  1  1/795 (0.13%)  1
Headache  1  1/795 (0.13%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disease  1  1/795 (0.13%)  1
Dyspnoea  1  1/795 (0.13%)  1
Pulmonary Embolism  1  1/795 (0.13%)  1
Vascular disorders   
Hypotension  1  1/795 (0.13%)  1
Peripheral Arterial Occlusive Disease  1  1/795 (0.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flurpiridaz F 18
Affected / at Risk (%) # Events
Total   555/795 (69.81%)    
Cardiac disorders   
Angina Pectoris  1  119/795 (14.97%)  119
Gastrointestinal disorders   
Nausea  1  44/795 (5.53%)  44
General disorders   
Fatigue  1  70/795 (8.81%)  70
Non-Cardiac Chest Pain  1  58/795 (7.30%)  58
Investigations   
Electrocardiogram ST Segment Depressions  1  75/795 (9.43%)  75
Nervous system disorders   
Dizziness  1  43/795 (5.41%)  43
Headache  1  129/795 (16.23%)  129
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  200/795 (25.16%)  200
Surgical and medical procedures   
Percutaneous coronary intervention  1  72/795 (9.06%)  72
Vascular disorders   
Flushing  1  60/795 (7.55%)  60
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: CMO
Organization: Lantheus Medical Imaging
Phone: 978-671-8544
Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01347710     History of Changes
Other Study ID Numbers: BMS747158-301
First Submitted: April 11, 2011
First Posted: May 4, 2011
Results First Submitted: January 24, 2016
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016