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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flurpiridaz F18 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flurpiridaz F18 | Drug | Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, | 60 days |
| 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 | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Cesare Orlandi, MD | Lantheus Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Associates of Mobile, Inc. | Mobile | Alabama | 36608 | United States | ||
| Scottsdale Medical Imaging, Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41064867 | Derived | Lopez DM, Huck DM, Divakaran S, Brown JM, Weber BN, Lemley M, Builoff V, Shanbhag A, Lan Z, Buckley C, Al-Mallah MH, Dorbala S, Blankstein R, Slomka P, Di Carli MF. Utility of 18F-Flurpiridaz PET Relative Flow Reserve in Differentiating Obstructive From Nonobstructive Coronary Artery Disease. Circ Cardiovasc Imaging. 2025 Nov;18(11):e018323. doi: 10.1161/CIRCIMAGING.125.018323. Epub 2025 Oct 9. | |
| 37807004 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flurpiridaz F 18 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 99mTechnicium (sestamibi or tetrofosmin) | Drug | Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis |
|
|
| 60 days |
| 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 | 60 days |
| 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 | 60 days |
| 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 | 60 days |
| 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 | 60 days |
| 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 | 60 days |
| 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 | 60 days |
| 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 | 60 days |
| 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 | 60 days |
| Diagnostic Certainty in PET MPI and SPECT MPI | Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule | 60 days |
| 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 | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Las Vegas Radiology | Las Vegas | Nevada | 89128 | 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 |
| Montefiore Medical Center | The Bronx | New York | 10467 | 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 |
| Derived |
| Poitrasson-Riviere A, Moody JB, Renaud JM, Hagio T, Arida-Moody L, Buckley CJ, Al-Mallah MH, Nallamothu BK, Weinberg RL, Ficaro EP, Murthy VL. Integrated myocardial flow reserve (iMFR) assessment: optimized PET blood flow quantification for diagnosis of coronary artery disease. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):136-146. doi: 10.1007/s00259-023-06455-2. Epub 2023 Oct 9. |
| 36401636 | Derived | 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. |
| 32703509 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population, received at least one dose of flurpiridaz F 18
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| ID | Title | Description |
|---|---|---|
| BG000 | Flurpiridaz F 18 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 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, | 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 | Posted | Number | 95% Confidence Interval | Proportion of true positive cases | 60 days |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | proportion of true postives | 60 days |
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| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | proportion of true negatives | 60 days |
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| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | Proportion of true positives | 60 days |
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| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | proportion of true negatives | 60 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | proportion of true positives | 60 days |
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| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | proportion of true negatives | 60 days |
|
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| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | proportion of true positives | 60 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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 | 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 | Posted | Number | 95% Confidence Interval | Proportion of true negatives | 60 days |
|
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| Secondary | 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 | 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 | Posted | Number | 95% Confidence Interval | proportion of true negatives | 60 days |
|
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| Secondary | 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 | 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 | Posted | Number | percent of images | 60 days |
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| Secondary | Diagnostic Certainty in PET MPI and SPECT MPI | Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule | 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 | Posted | Number | proportion of patients | 60 days |
|
|
Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flurpiridaz F 18 | 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 | 20 | 795 | 555 | 795 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Catheter Site Haemorrhage | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Electrocardiogram ST Segment Depressions | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CMO | Lantheus Medical Imaging | 978-671-8544 | c.orlandi@lantheus.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C525920 | BMS 747158-02 |
| D017256 | Technetium Tc 99m Sestamibi |
| C078700 | technetium tc-99m tetrofosmin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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