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CompletedNCT01347710Updated Nov 24, 2020Results posted

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

A Phase 3 interventional study of Flurpiridaz F18 and 99mTechnicium (sestamibi or tetrofosmin) in Coronary Artery Disease, sponsored by Lantheus Medical Imaging. Completed at 81 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Lantheus Medical Imaging · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
795
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).

Read the detailed description

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary Artery Disease.
  • Positron Emission Tomography Myocardial Perfusion Imaging.
  • Single Positron Emission Computed Tomography.
  • Flurpiridaz F18 Injection.
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 795 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Lantheus Medical Imaging is the lead sponsor of 30 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.

Exclusion criteria

Exclusion Criteria:

Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control.

Unstable cardiac status. History of coronary artery bypass graft. History of percutaneous coronary intervention within the past six months. See protocol for additional details.

05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
795 participants (actual)

Study arms

  • Experimental
    Flurpiridaz F18

    Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

    Drug: Flurpiridaz F18 · Drug: 99mTechnicium (sestamibi or tetrofosmin)

Interventions

  • DrugFlurpiridaz F18

    Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis

    Also known as: flurpiridaz F 18

  • Drug99mTechnicium (sestamibi or tetrofosmin)

    Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis

    Also known as: 99mTc sestamibi or 99mTc Tetrofosmin

06

What researchers measure

Primary outcomes

  1. Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity

    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

  2. Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity

    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

Secondary outcomes

  1. Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.

    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

  2. Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.

    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

  3. Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).

    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

  4. Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).

    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

  5. Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).

    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

  6. Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).

    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

  7. Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good

    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

  8. Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good

    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

  9. Image Quality of Rest and Stress (PET vs SPECT).

    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

  10. Diagnostic Certainty in PET MPI and SPECT MPI

    Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule

    Time frame: 60 days

07

Results

Posted Apr 5, 2016

Participant flow

Participant flow — Overall Study
MilestoneFlurpiridaz F 18
Started795
Completed764
Not completed31
Withdrew: Withdrawal by subject2
Withdrew: Adverse event4
Withdrew: Angio or spect not completed18
Withdrew: Issue with vitals prior to dosing1
Withdrew: Lost to follow-up1
Withdrew: Physician decision2
Withdrew: Other3

Outcome measures

PrimaryDiagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity

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
Reported as:
Number · Proportion of true positive cases
Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
Proportion of true positive casesFlurpiridaz F18 PET MPI
PET MPI sensitivity.719 (.670 to .763)
SPECT MPI Sensitivity.537 (.485 to .588)
Statistical analysis
  • Flurpiridaz F18 PET MPI · McNemar · p = <0.001 (P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule)Two-sided McNemar's (chi-squared) test superiority
SecondaryDiagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.

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
Reported as:
Number · proportion of true postives
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
proportion of true postivesFlurpiridaz F18 PET MPI
PET sensitivity pharmacologic stress0.736 (.679 to .785)
SPECT sensitivity pharmacologic stress0.533 (.472 to .592)
PET sensitivity in females0.644 (.517 to .754)
SPECT sensitivity in females0.356 (.246 to .483)
PET sensitivity BMI >/=300.722 (.653 to .782)
SPECT sensitivity BMI >/=300.533 (.461 to .605)
Statistical analysis
  • Flurpiridaz F18 PET MPI · McNemar · p = <0.001 (p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress)Two-sided McNemar's (chi-squared) test superiority
  • Flurpiridaz F18 PET MPI · McNemar · p = <0.001 (p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females)p-Value based on two-sided McNemar's (Chi-squared) test superiority
  • Flurpiridaz F18 PET MPI · McNemar · p = <0.001 (p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI \>/=30)p-Value based on two-sided McNemar's (Chi-squared) test superiority
SecondaryDiagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.

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
Reported as:
Number · proportion of true negatives
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
proportion of true negativesFlurpiridaz F18 PET MPI
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)
Statistical analysis
  • Flurpiridaz F18 PET MPI · Z test · p = 0.891 (p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress)z test for non inferiority for specificity
  • Flurpiridaz F18 PET MPI · z test · p = .546 (p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients)z test for non-inferiority for specificity
  • Flurpiridaz F18 PET MPI · z test · p = .538 (p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI \>/=30)z test for non-inferiority for specificity
SecondaryDiagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).

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
Reported as:
Number · Proportion of true positives
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
Proportion of true positivesFlurpiridaz F 18
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)
Statistical analysis
  • Flurpiridaz F 18 · McNemar · p = <0.001 (p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD)Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD
  • Flurpiridaz F 18 · McNemar · p = <0.001 (p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX)p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX
  • Flurpiridaz F 18 · McNemar · p = <0.001 (p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA)p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA
  • Flurpiridaz F 18 · McNemar · p = <0.001 (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)p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD
SecondaryDiagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).

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
Reported as:
Number · proportion of true negatives
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
proportion of true negativesFlurpiridaz F 18
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)
Statistical analysis
  • Flurpiridaz F 18 · z Test · p = .379 (p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD)z test for non-inferiority for specificity; LAD
  • Flurpiridaz F 18 · Z Test · p = .358 (p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX)z test for non-inferiority for specificity; LCX
  • Flurpiridaz F 18 · z Test · p = .442 (p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA)z test for non-inferiority for specificity; RCA
  • Flurpiridaz F 18 · z Test · p = .984 (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)z test for non-inferiority for specificity; non-LAD
SecondaryDiagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).

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
Reported as:
Number · proportion of true positives
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
proportion of true positivesFlurpiridaz F18 PET MPI
PET MPI sensitivity; multivessel disease.410 (.340 to .484)
SPECT MPI sensitivity; multivessel disease.275 (.215 to .345)
Statistical analysis
  • Flurpiridaz F18 PET MPI · McNemar · p = <0.001 (p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease)p-Value based on two-sided McNemar's (Chi squared) test superiority
SecondaryDiagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).

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
Reported as:
Number · proportion of true negatives
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
proportion of true negativesFlurpiridaz F18 PET MPI
PET MPI specificity; multivessel disease.882 (.853 to .906)
SPECT MPI specificity; multivessel disease.964 (.945 to .976)
Statistical analysis
  • Flurpiridaz F18 PET MPI · z test · p = 0.827 (p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease)p-Value based on one-sided z test for non-inferiority
SecondaryOverall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good

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
Reported as:
Number · proportion of true positives
Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good
proportion of true positivesFlurpiridaz F18 PET MPI
PET MPI sensitivity; image quality excellent/good.711 (.658 to .759)
SPECT MPI sensitivity image quality excellent/good.539 (.483 to .594)
Statistical analysis
  • Flurpiridaz F18 PET MPI · McNemar · p = <0.001 (p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good)p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity
PrimaryDiagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity

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
Reported as:
Number · Proportion of true negatives
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
Proportion of true negativesFlurpiridaz F18
PET MPI Specificity.762 (.718 to .801)
SPECT MPI Specificity.868 (.832 to .898)
Statistical analysis
  • Flurpiridaz F18 · Z Test · p = .945 (p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI)one-sided z test for non-inferiority for specificity
SecondaryOverall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good

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
Reported as:
Number · proportion of true negatives
Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good
proportion of true negativesFlurpiridaz F18 PET MPI
PET MPI specificity; image quality excellent/good.769 (.721 to .811)
SPECT MPI specificity image quality excellent/good.880 (.841 to .911)
Statistical analysis
  • Flurpiridaz F18 PET MPI · z Test · p = 0.954 (p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good)p-Value based on on-sided z test for non-inferiority for specificity
SecondaryImage Quality of Rest and Stress (PET vs SPECT).

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
Reported as:
Number · percent of images
Image Quality of Rest and Stress (PET vs SPECT).
percent of imagesFlurpiridaz F18 PET MPI
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
Statistical analysis
  • Flurpiridaz F18 PET MPI · Log Rank · p = <0.001
SecondaryDiagnostic Certainty in PET MPI and SPECT MPI

Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule

Time frame:
60 days
Reported as:
Number · proportion of patients
Diagnostic Certainty in PET MPI and SPECT MPI
proportion of patientsFlurpiridaz F 18
PET definitely normal/abnormal0.862
PET probably/equivocal0.138
SPECT definitely normal/abnormal0.799
SPECT probably/equivocal0.201
Statistical analysis
  • Flurpiridaz F 18 · McNemar · p = <0.001p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT

Adverse events

Collected over Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Flurpiridaz F 18—20/795 (2.5%)555/795 (69.8%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventFlurpiridaz F 18
Angina PectorisCardiac disorders6/795
Ventricular TachycardiaCardiac disorders2/795
Atrial FlutterCardiac disorders1/795
Cardiac Failure CongestiveCardiac disorders1/795
Cardiogenic ShockCardiac disorders1/795
Inguinal HerniaGastrointestinal disorders1/795
Catheter Site HaemorrhageGeneral disorders1/795
Non-Cardiac Chest PainGeneral disorders1/795
PneumoniaInfections and infestations1/795
HypoglycaemiaMetabolism and nutrition disorders1/795
Most frequent other events
Most frequent other events
EventFlurpiridaz F 18
DyspnoeaRespiratory, thoracic and mediastinal disorders200/795
HeadacheNervous system disorders129/795
Angina PectorisCardiac disorders119/795
Electrocardiogram ST Segment DepressionsInvestigations75/795
Percutaneous coronary interventionSurgical and medical procedures72/795
FatigueGeneral disorders70/795
FlushingVascular disorders60/795
Non-Cardiac Chest PainGeneral disorders58/795
NauseaGastrointestinal disorders44/795
DizzinessNervous system disorders43/795

Baseline characteristics

Safety population, received at least one dose of flurpiridaz F 18

Age, Categorical
Age, Categorical(Participants)Flurpiridaz F 18
<=18 years0
Between 18 and 65 years458
>=65 years337
Sex: Female, Male
Sex: Female, Male(Participants)Flurpiridaz F 18
Female249
Male546
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Flurpiridaz F 18
Hispanic or Latino43
Not Hispanic or Latino708
Unknown or Not Reported44
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Flurpiridaz F 18
American Indian or Alaska Native2
Asian8
Native Hawaiian or Other Pacific Islander4
Black or African American105
White652
More than one race0
Unknown or Not Reported24
08

Study locations

81 sites
  • Cardiology Associates of Mobile, Inc.
    Mobile, Alabama 36608, United States
  • Scottsdale Medical Imaging, Ltd.
    Scottsdale, Arizona 85258, United States
  • West Side Medical Associates of Los Angeles
    Beverly Hills, California 90211, United States
  • USC PET Imaging Science Center
    Los Angeles, California 90033, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • VA West Los Angeles Medical Center
    Los Angeles, California 90073, United States
  • UCLA
    Los Angeles, California 90095, United States
  • Veterans Affairs Palo Alto Health Care System
    Palo Alto, California 94304, United States
  • Cardiovascular Consultants Medical Group
    Pleasant Hill, California 94523, United States
  • Northern California PET Imaging Center-Palo Alto
    Sacramento, California 95816, United States
  • VA San Diego Healthcare System
    San Diego, California 92161, United States
  • UCSF Medical Center
    San Francisco, California 94107, United States
  • Yale University
    New Haven, Connecticut 06519, United States
  • Alfieri Cardiology
    Newark, Delaware 19713, United States
  • Christiana Care Health System
    Newark, Delaware 19718, United States
  • Elite Research and Clinical Trials
    Aventura, Florida 33180, United States
  • Independent Imaging, LLC
    Boynton Beach, Florida 33437, United States
  • Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida
    Clearwater, Florida 33756, United States
  • Florida Heart Associates
    Fort Myers, Florida 33907, United States
  • St. Luke's Cardiology Associates
    Jacksonville, Florida 32216, United States
  • The Cardiovascular Center, PA
    Lake Mary, Florida 32746, United States
  • Florida Hospital/Cardiovascular Institute (Florida Heart Group)
    Orlando, Florida 32803, United States
  • South Florida Research Solutions
    Pembroke Pines, Florida 33028, United States
  • Memorial Hospital of Tampa
    Tampa, Florida 33609, United States
  • Georgia Health Sciences Univ/Med College of GA
    Augusta, Georgia 30912, United States
  • South Coast Imaging Center
    Savannah, Georgia 31406, United States
  • Gateway Cardiology, PC
    Jerseyville, Illinois 62052, United States
  • Norton Cardiovascular Associates
    Louisville, Kentucky 40205-3372, United States
  • Biomedical Research Foundation of Northwest Louisiana
    Shreveport, Louisiana 71133-8050, United States
  • Maine Research Associates
    Auburn, Maine 04210, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287-0817, United States
  • Mass General Hospital (MGH)
    Boston, Massachusetts 02114, United States
  • Boston University Medical Center
    Boston, Massachusetts 02118, United States
  • University of Michigan Health System
    Ann Arbor, Michigan 48109-5873, United States
  • Wayne State University - Harper University Hospital
    Detroit, Michigan 48201, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • St. Mary's Healthcare (Trinity Health)
    Grand Rapids, Michigan 49503, United States
  • McLaren Macomb
    Mount Clemens, Michigan 48043, United States
  • William Beaumont Hospital
    Royal Oak, Michigan 48073-6769, United States
  • Hattiesburg Clinic
    Hattiesburg, Mississippi 39401, United States
  • Missouri Cardiovascular Specialists, LLP
    Columbia, Missouri 65201, United States
  • Cardiovascular Imaging Technologies (CVIT)
    Kansas City, Missouri 64111, United States
  • Saint Louis University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Las Vegas Radiology
    Las Vegas, Nevada 89128, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • St. Francis Hospital
    Roslyn, New York 11576, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • OhioHealth Research Institute
    Columbus, Ohio 43214, United States
  • Kettering Medical Center
    Kettering, Ohio 45429, United States
  • Pinnacle Health Cardiovascular Institute/ Associated Cardiologists
    Harrisburg, Pennsylvania 17110, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Presbyterian University Hospital
    Pittsburgh, Pennsylvania 15213, United States
  • Berks Cardiologists, Ltd.
    Wyomissing, Pennsylvania 19610, United States
  • York Hospital /Wellspan Health
    York, Pennsylvania 17405, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Wellmont CVA Heart Institute
    Kingsport, Tennessee 37660, United States
  • Center for Biomedical Research
    Knoxville, Tennessee 37909, United States
  • Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.
    Knoxville, Tennessee 37917, United States
  • Vanderbilt Heart and Vascular Institute
    Nashville, Tennessee 37232, United States
  • Dallas VA Medical Center
    Dallas, Texas 75216, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555-0709, United States
  • Excel Diagnostics and Nuclear Oncology Center
    Houston, Texas 77042, United States
  • Katy Cardiology
    Katy, Texas 77493, United States
  • West Houston Area Clinical Trial Consultants, LLC
    Tomball, Texas 77375, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
  • McGuire Veteran Affairs Medical Center
    Richmond, Virginia 23249, United States
  • Carilion Cardiology Clinic
    Roanoke, Virginia 24014, United States
  • Roanoke Heart Institute
    Roanoke, Virginia 24014, United States
  • University of Western Ontario
    London, Ontario N6A 5A5, Canada
  • KMH Cardiology and Diagnostic and MRI Centres
    Mississauga, Ontario L5K 2L3, Canada
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y 4W7, Canada
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)
    Sherbrooke, Quebec J1H 5N4, Canada
  • Helsinki University Hospital
    Helsinki, 00029 HUS, Finland
  • Turku PET Centre
    Turku, FI-20520, Finland
  • San Patricio MEDFLIX (San Patricio MRI & CT Center)
    Guaynabo, 00968, Puerto Rico
  • VA Caribbean Healthcare System
    San Juan, 00921, Puerto Rico
09

References and documents

Publications

  • Hagio T, Moody JB, Poitrasson-Riviere A, Renaud JM, Pierce L, Buckley C, Ficaro EP, Murthy VL. Multi-center, multi-vendor validation of deep learning-based attenuation correction in SPECT MPI: data from the international flurpiridaz-301 trial. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1028-1033. doi: 10.1007/s00259-022-06045-8. Epub 2022 Nov 19. PubMed 36401636 ↗
  • Maddahi J, Lazewatsky J, Udelson JE, Berman DS, Beanlands RSB, Heller GV, Bateman TM, Knuuti J, Orlandi C. Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Evaluation of Coronary Artery Disease. J Am Coll Cardiol. 2020 Jul 28;76(4):391-401. doi: 10.1016/j.jacc.2020.05.063. PubMed 32703509 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01347710
Lead sponsor
Lantheus Medical Imaging
Responsible party
Sponsor
First posted
May 4, 2011
Start date
Jun 2011
Primary completion
Jul 2013
Completion
Sep 2013
Results posted
Apr 5, 2016
Last update
Nov 24, 2020

Study contacts

Cesare Orlandi, MD
study director · Lantheus Medical Imaging

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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