Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging
Positron emission tomography (PET) myocardial perfusion imaging (MPI) with the novel radiopharmaceutical Fluorine-18 Flurpiridaz has been shown in Phase 1, 2, and first Phase 3 clinical studies to be safe and effective in diagnosing coronary artery disease (CAD). We describe the methodology of the s...
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| Veröffentlicht in: | Journal of nuclear cardiology 2021-06, Vol.28 (3), p.1105-1116 |
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| creator | Bourque, Jamieson M. Hanson, Christopher A. Agostini, Denis Bateman, Timothy M. Bax, Jeroen J. Beanlands, Rob S.B. Berman, Daniel S. Garcia, Ernest V. Heller, Gary V. Knuuti, Juhani Tamaki, Nagara Udelson, James E. Maddahi, Jamshid |
| description | Positron emission tomography (PET) myocardial perfusion imaging (MPI) with the novel radiopharmaceutical Fluorine-18 Flurpiridaz has been shown in Phase 1, 2, and first Phase 3 clinical studies to be safe and effective in diagnosing coronary artery disease (CAD). We describe the methodology of the second FDA-mandated phase 3 prospective, open-label, international, multi-center trial of F-18 Flurpiridaz PET MPI.
The primary study end point is to assess the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD [≥ 50% by quantitative invasive coronary angiography (ICA)] in patients with suspected CAD. The secondary endpoints are to evaluate the diagnostic efficacy of F-18 Flurpiridaz PET MPI compared to Tc-99 m-labeled SPECT MPI in the detection of CAD in all patients and in the following subgroups: (1) females; (2) patients with body mass index ≥ 30 kg/m2; and (3) diabetic patients. This trial’s design differs from the first phase 3 trial in that (1) comparison to SPECT is now a secondary end point; (2) patients with known CAD are excluded; and (3) both SPECT and PET MPI are performed before ICA.
This second phase 3 study will provide additional evidence on the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD.
NCT03354273 |
| doi_str_mv | 10.1007/s12350-021-02527-8 |
| format | Article |
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The primary study end point is to assess the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD [≥ 50% by quantitative invasive coronary angiography (ICA)] in patients with suspected CAD. The secondary endpoints are to evaluate the diagnostic efficacy of F-18 Flurpiridaz PET MPI compared to Tc-99 m-labeled SPECT MPI in the detection of CAD in all patients and in the following subgroups: (1) females; (2) patients with body mass index ≥ 30 kg/m2; and (3) diabetic patients. This trial’s design differs from the first phase 3 trial in that (1) comparison to SPECT is now a secondary end point; (2) patients with known CAD are excluded; and (3) both SPECT and PET MPI are performed before ICA.
This second phase 3 study will provide additional evidence on the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD.
NCT03354273</description><identifier>ISSN: 1071-3581</identifier><identifier>EISSN: 1532-6551</identifier><identifier>DOI: 10.1007/s12350-021-02527-8</identifier><identifier>PMID: 33521873</identifier><language>eng</language><publisher>Cham: Elsevier Inc</publisher><subject>Cardiac PET ; Cardiology ; Cardiovascular disease ; Cardiovascular imaging ; Clinical Trials, Phase III as Topic ; Coronary artery disease ; Coronary Artery Disease - diagnostic imaging ; Coronary vessels ; F-18 flurpiridaz ; Humans ; Imaging ; Medicine ; Medicine & Public Health ; Multicenter Studies as Topic ; Myocardial Perfusion Imaging ; Nuclear Medicine ; Original Article ; Positron-Emission Tomography ; Pyridazines ; Radiology ; Radiotracers ; Research Design ; Tomography</subject><ispartof>Journal of nuclear cardiology, 2021-06, Vol.28 (3), p.1105-1116</ispartof><rights>2021 American Society of Nuclear Cardiology. Published by ELSEVIER INC. All rights reserved.</rights><rights>American Society of Nuclear Cardiology 2021</rights><rights>American Society of Nuclear Cardiology 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-76bc0275bfea424c6018ee29f396891bcf40933c6337a697ffb25a05692018e3</citedby><cites>FETCH-LOGICAL-c494t-76bc0275bfea424c6018ee29f396891bcf40933c6337a697ffb25a05692018e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12350-021-02527-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12350-021-02527-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33521873$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bourque, Jamieson M.</creatorcontrib><creatorcontrib>Hanson, Christopher A.</creatorcontrib><creatorcontrib>Agostini, Denis</creatorcontrib><creatorcontrib>Bateman, Timothy M.</creatorcontrib><creatorcontrib>Bax, Jeroen J.</creatorcontrib><creatorcontrib>Beanlands, Rob S.B.</creatorcontrib><creatorcontrib>Berman, Daniel S.</creatorcontrib><creatorcontrib>Garcia, Ernest V.</creatorcontrib><creatorcontrib>Heller, Gary V.</creatorcontrib><creatorcontrib>Knuuti, Juhani</creatorcontrib><creatorcontrib>Tamaki, Nagara</creatorcontrib><creatorcontrib>Udelson, James E.</creatorcontrib><creatorcontrib>Maddahi, Jamshid</creatorcontrib><title>Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging</title><title>Journal of nuclear cardiology</title><addtitle>J. Nucl. Cardiol</addtitle><addtitle>J Nucl Cardiol</addtitle><description>Positron emission tomography (PET) myocardial perfusion imaging (MPI) with the novel radiopharmaceutical Fluorine-18 Flurpiridaz has been shown in Phase 1, 2, and first Phase 3 clinical studies to be safe and effective in diagnosing coronary artery disease (CAD). We describe the methodology of the second FDA-mandated phase 3 prospective, open-label, international, multi-center trial of F-18 Flurpiridaz PET MPI.
The primary study end point is to assess the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD [≥ 50% by quantitative invasive coronary angiography (ICA)] in patients with suspected CAD. The secondary endpoints are to evaluate the diagnostic efficacy of F-18 Flurpiridaz PET MPI compared to Tc-99 m-labeled SPECT MPI in the detection of CAD in all patients and in the following subgroups: (1) females; (2) patients with body mass index ≥ 30 kg/m2; and (3) diabetic patients. This trial’s design differs from the first phase 3 trial in that (1) comparison to SPECT is now a secondary end point; (2) patients with known CAD are excluded; and (3) both SPECT and PET MPI are performed before ICA.
This second phase 3 study will provide additional evidence on the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD.
NCT03354273</description><subject>Cardiac PET</subject><subject>Cardiology</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular imaging</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Coronary artery disease</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary vessels</subject><subject>F-18 flurpiridaz</subject><subject>Humans</subject><subject>Imaging</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Multicenter Studies as Topic</subject><subject>Myocardial Perfusion Imaging</subject><subject>Nuclear Medicine</subject><subject>Original Article</subject><subject>Positron-Emission Tomography</subject><subject>Pyridazines</subject><subject>Radiology</subject><subject>Radiotracers</subject><subject>Research Design</subject><subject>Tomography</subject><issn>1071-3581</issn><issn>1532-6551</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1u1DAUhSMEomXgBVggS2wGiYB_4vwgNlXVAlIlWMw-cpzrGY8SO_gmSMO78i7c6RQqddGFZcv-zvW592TZa8E_CM6rjyik0jznUtDSssrrJ9m50ErmpdbiKZ15JXKla3GWvUDcc84b1TTPszOltBR1pc6zPxeIgOjDlo2HaE3qvRnYBMkt6GNgPjBccAI7Q89sTDGYdGAmzUBb7xEMwieWzEywGYCZ0LMe0G8Di47NO2AINtLltCOSqfcsThDywXQwsHEZZp9bCFSN4bz0h6PIDUuafPK9-c3W17mo35GLPTk4-nExsSmin8kJg9Hjrcs5jnGbzLQ7sPWPqw0JRrOlnl5mz5wZEF7d7atsc321ufya33z_8u3y4ia3RVPMeVV2lstKdw5MIQtbclEDyMappqwb0VlX0OSULZWqTNlUznVSG67LRh5JtcrWp7JTij8XwLklYxaGwQSIC7ayqAuhy4ImvsrePkD3cUk0OqJ0UemqUBUnSp4omyJiAtdOiVpKh1bw9ph9e8q-pezb2-zbmkRv7kov3Qj9f8m_sAlQJwDpKWwh3f_9aNnPJxXQAH95UqH1ECz0PlEobR_9Y_K_0rjQdQ</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Bourque, Jamieson M.</creator><creator>Hanson, Christopher A.</creator><creator>Agostini, Denis</creator><creator>Bateman, Timothy M.</creator><creator>Bax, Jeroen J.</creator><creator>Beanlands, Rob S.B.</creator><creator>Berman, Daniel S.</creator><creator>Garcia, Ernest V.</creator><creator>Heller, Gary V.</creator><creator>Knuuti, Juhani</creator><creator>Tamaki, Nagara</creator><creator>Udelson, James E.</creator><creator>Maddahi, Jamshid</creator><general>Elsevier Inc</general><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20210601</creationdate><title>Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging</title><author>Bourque, Jamieson M. ; Hanson, Christopher A. ; Agostini, Denis ; Bateman, Timothy M. ; Bax, Jeroen J. ; Beanlands, Rob S.B. ; Berman, Daniel S. ; Garcia, Ernest V. ; Heller, Gary V. ; Knuuti, Juhani ; Tamaki, Nagara ; Udelson, James E. ; Maddahi, Jamshid</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-76bc0275bfea424c6018ee29f396891bcf40933c6337a697ffb25a05692018e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Cardiac PET</topic><topic>Cardiology</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular imaging</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Coronary artery disease</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary vessels</topic><topic>F-18 flurpiridaz</topic><topic>Humans</topic><topic>Imaging</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Multicenter Studies as Topic</topic><topic>Myocardial Perfusion Imaging</topic><topic>Nuclear Medicine</topic><topic>Original Article</topic><topic>Positron-Emission Tomography</topic><topic>Pyridazines</topic><topic>Radiology</topic><topic>Radiotracers</topic><topic>Research Design</topic><topic>Tomography</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bourque, Jamieson M.</creatorcontrib><creatorcontrib>Hanson, Christopher A.</creatorcontrib><creatorcontrib>Agostini, Denis</creatorcontrib><creatorcontrib>Bateman, Timothy M.</creatorcontrib><creatorcontrib>Bax, Jeroen J.</creatorcontrib><creatorcontrib>Beanlands, Rob S.B.</creatorcontrib><creatorcontrib>Berman, Daniel S.</creatorcontrib><creatorcontrib>Garcia, Ernest V.</creatorcontrib><creatorcontrib>Heller, Gary V.</creatorcontrib><creatorcontrib>Knuuti, Juhani</creatorcontrib><creatorcontrib>Tamaki, Nagara</creatorcontrib><creatorcontrib>Udelson, James E.</creatorcontrib><creatorcontrib>Maddahi, Jamshid</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of nuclear cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bourque, Jamieson M.</au><au>Hanson, Christopher A.</au><au>Agostini, Denis</au><au>Bateman, Timothy M.</au><au>Bax, Jeroen J.</au><au>Beanlands, Rob S.B.</au><au>Berman, Daniel S.</au><au>Garcia, Ernest V.</au><au>Heller, Gary V.</au><au>Knuuti, Juhani</au><au>Tamaki, Nagara</au><au>Udelson, James E.</au><au>Maddahi, Jamshid</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging</atitle><jtitle>Journal of nuclear cardiology</jtitle><stitle>J. Nucl. Cardiol</stitle><addtitle>J Nucl Cardiol</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>28</volume><issue>3</issue><spage>1105</spage><epage>1116</epage><pages>1105-1116</pages><issn>1071-3581</issn><eissn>1532-6551</eissn><abstract>Positron emission tomography (PET) myocardial perfusion imaging (MPI) with the novel radiopharmaceutical Fluorine-18 Flurpiridaz has been shown in Phase 1, 2, and first Phase 3 clinical studies to be safe and effective in diagnosing coronary artery disease (CAD). We describe the methodology of the second FDA-mandated phase 3 prospective, open-label, international, multi-center trial of F-18 Flurpiridaz PET MPI.
The primary study end point is to assess the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD [≥ 50% by quantitative invasive coronary angiography (ICA)] in patients with suspected CAD. The secondary endpoints are to evaluate the diagnostic efficacy of F-18 Flurpiridaz PET MPI compared to Tc-99 m-labeled SPECT MPI in the detection of CAD in all patients and in the following subgroups: (1) females; (2) patients with body mass index ≥ 30 kg/m2; and (3) diabetic patients. This trial’s design differs from the first phase 3 trial in that (1) comparison to SPECT is now a secondary end point; (2) patients with known CAD are excluded; and (3) both SPECT and PET MPI are performed before ICA.
This second phase 3 study will provide additional evidence on the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD.
NCT03354273</abstract><cop>Cham</cop><pub>Elsevier Inc</pub><pmid>33521873</pmid><doi>10.1007/s12350-021-02527-8</doi><tpages>12</tpages></addata></record> |
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| subjects | Cardiac PET Cardiology Cardiovascular disease Cardiovascular imaging Clinical Trials, Phase III as Topic Coronary artery disease Coronary Artery Disease - diagnostic imaging Coronary vessels F-18 flurpiridaz Humans Imaging Medicine Medicine & Public Health Multicenter Studies as Topic Myocardial Perfusion Imaging Nuclear Medicine Original Article Positron-Emission Tomography Pyridazines Radiology Radiotracers Research Design Tomography |
| title | Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging |
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