Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions
Objectives To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety. Methods This prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) wi...
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| Veröffentlicht in: | Abdominal imaging 2021-10, Vol.46 (10), p.4647-4659 |
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| creator | Lv, Ke Zhai, Hongyan Jiang, Yuxin Liang, Ping Xu, Hui-Xiong Du, Lianfang Chou, Yi-Hong Xie, Xiaoyan Luo, YuKun Lee, Young Joon Lee, Jae Young Hu, Bing Luo, Baoming Wang, Yi Luan, Ying Kalli, Christina Chen, Kun Wang, Wenping Liang, Ja-Der |
| description | Objectives
To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety.
Methods
This prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) ( |
| doi_str_mv | 10.1007/s00261-021-03010-1 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8435522</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2542362149</sourcerecordid><originalsourceid>FETCH-LOGICAL-c381t-aeeb5342b8c575bc1ce809e090507f37d4aa3b83ac39c48fa894700b249b20c13</originalsourceid><addsrcrecordid>eNp9kc9u1DAQxiMEolXpC3CyxIVLYPwvcS5IqKKAVAQSBXGzHO9k6yprLxmnaHkOnoOH4MlwdqsiOHCwPOP5zecZfVX1mMMzDtA-JwDR8BpEORI41PxedSxk09QA2ty_i9WXo-qU6BoAeKM5F_phdSQVl00nm-Pqx4cp0RZ9DjfIHBESbTBmlga2Cm4dE-XgGQ5D8M7vmIsrRm7AvFuIjym67ymsLt_tCyVNn2f89ZPNY54cpbk8-hSXODO3LrrEQmRbl8M-_hbyFRuSdyMby_8TG5FCivSoejC4kfD09j6pPp2_ujx7U1-8f_327OVF7aXhuXaIvZZK9MbrVveeezTQIXSgoR1ku1LOyd5I52XnlRmc6VQL0AvV9QI8lyfVi4Pudu43uPK4jDra7RQ2btrZ5IL9uxLDlV2nG2uU1FqIIvD0VmBKX2ekbDeBPI6ji5hmskKrYoPgqivok3_Q6zRPsaxXqJa3jeyMKZQ4UL7YQhMOd8NwsIvv9uC7Lb7bve92WUMemqjAcY3TH-n_dP0GsX2zAw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2571763988</pqid></control><display><type>article</type><title>Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions</title><source>SpringerLink Journals - AutoHoldings</source><creator>Lv, Ke ; Zhai, Hongyan ; Jiang, Yuxin ; Liang, Ping ; Xu, Hui-Xiong ; Du, Lianfang ; Chou, Yi-Hong ; Xie, Xiaoyan ; Luo, YuKun ; Lee, Young Joon ; Lee, Jae Young ; Hu, Bing ; Luo, Baoming ; Wang, Yi ; Luan, Ying ; Kalli, Christina ; Chen, Kun ; Wang, Wenping ; Liang, Ja-Der</creator><creatorcontrib>Lv, Ke ; Zhai, Hongyan ; Jiang, Yuxin ; Liang, Ping ; Xu, Hui-Xiong ; Du, Lianfang ; Chou, Yi-Hong ; Xie, Xiaoyan ; Luo, YuKun ; Lee, Young Joon ; Lee, Jae Young ; Hu, Bing ; Luo, Baoming ; Wang, Yi ; Luan, Ying ; Kalli, Christina ; Chen, Kun ; Wang, Wenping ; Liang, Ja-Der</creatorcontrib><description>Objectives
To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety.
Methods
This prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) (< 10 cm in diameter) underwent a contrast-enhanced ultrasound (CEUS) examination (218 received Sonazoid of 0.12 μL microbubbles/kg; 206 received SonoVue of 2.4 mL). Three independent blinded readers evaluated pre- and post-contrast images characterising the FLLs as benign or malignant.
Results
Sonazoid-enhanced and SonoVue-enhanced ultrasound provided a statistically significant improvement in specificity for all 3 readers comparing to unenhanced ultrasound (for Sonazoid:
p
= 0.0093, < 0.0001, 0.0011; for SonoVue:
p
= 0.002, 0.03, 0.12, respectively). Difference in accuracy improvement between the 2 groups was within the pre-specified non-inferiority margin of 20% for all 3 readers (6.1%, 95% CI: − 5.0 to 17.2; − 7.5%, 95% CI: − 18.4 to 3.5; − 0.3%, 95% CI: − 11.3 to 10.7).
The diagnostic confidence level for all 3 readers increased with post-contrast images relative to pre-contrast images. Both contrast agents were well tolerated.
Conclusion
Results showed a similar efficacy for Sonazoid™ and SonoVue® in diagnosing FLLs as benign or malignant, and underlined the benefit of CEUS imaging over unenhanced ultrasound imaging in reaching a confident diagnosis without having to refer patients for additional imaging exams.</description><identifier>ISSN: 2366-004X</identifier><identifier>ISSN: 2366-0058</identifier><identifier>EISSN: 2366-0058</identifier><identifier>DOI: 10.1007/s00261-021-03010-1</identifier><identifier>PMID: 34136936</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Confidence intervals ; Contrast agents ; Contrast media ; Diagnostic systems ; Gastroenterology ; Hepatobiliary ; Hepatology ; Image contrast ; Image enhancement ; Imaging ; Lesions ; Liver ; Medical diagnosis ; Medical imaging ; Medicine ; Medicine & Public Health ; Radiology ; Safety ; Statistical analysis ; Ultrasonic imaging ; Ultrasound</subject><ispartof>Abdominal imaging, 2021-10, Vol.46 (10), p.4647-4659</ispartof><rights>The Author(s) 2021</rights><rights>The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021. The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c381t-aeeb5342b8c575bc1ce809e090507f37d4aa3b83ac39c48fa894700b249b20c13</citedby><cites>FETCH-LOGICAL-c381t-aeeb5342b8c575bc1ce809e090507f37d4aa3b83ac39c48fa894700b249b20c13</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/s00261-021-03010-1$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00261-021-03010-1$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27903,27904,41467,42536,51297</link.rule.ids></links><search><creatorcontrib>Lv, Ke</creatorcontrib><creatorcontrib>Zhai, Hongyan</creatorcontrib><creatorcontrib>Jiang, Yuxin</creatorcontrib><creatorcontrib>Liang, Ping</creatorcontrib><creatorcontrib>Xu, Hui-Xiong</creatorcontrib><creatorcontrib>Du, Lianfang</creatorcontrib><creatorcontrib>Chou, Yi-Hong</creatorcontrib><creatorcontrib>Xie, Xiaoyan</creatorcontrib><creatorcontrib>Luo, YuKun</creatorcontrib><creatorcontrib>Lee, Young Joon</creatorcontrib><creatorcontrib>Lee, Jae Young</creatorcontrib><creatorcontrib>Hu, Bing</creatorcontrib><creatorcontrib>Luo, Baoming</creatorcontrib><creatorcontrib>Wang, Yi</creatorcontrib><creatorcontrib>Luan, Ying</creatorcontrib><creatorcontrib>Kalli, Christina</creatorcontrib><creatorcontrib>Chen, Kun</creatorcontrib><creatorcontrib>Wang, Wenping</creatorcontrib><creatorcontrib>Liang, Ja-Der</creatorcontrib><title>Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions</title><title>Abdominal imaging</title><addtitle>Abdom Radiol</addtitle><description>Objectives
To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety.
Methods
This prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) (< 10 cm in diameter) underwent a contrast-enhanced ultrasound (CEUS) examination (218 received Sonazoid of 0.12 μL microbubbles/kg; 206 received SonoVue of 2.4 mL). Three independent blinded readers evaluated pre- and post-contrast images characterising the FLLs as benign or malignant.
Results
Sonazoid-enhanced and SonoVue-enhanced ultrasound provided a statistically significant improvement in specificity for all 3 readers comparing to unenhanced ultrasound (for Sonazoid:
p
= 0.0093, < 0.0001, 0.0011; for SonoVue:
p
= 0.002, 0.03, 0.12, respectively). Difference in accuracy improvement between the 2 groups was within the pre-specified non-inferiority margin of 20% for all 3 readers (6.1%, 95% CI: − 5.0 to 17.2; − 7.5%, 95% CI: − 18.4 to 3.5; − 0.3%, 95% CI: − 11.3 to 10.7).
The diagnostic confidence level for all 3 readers increased with post-contrast images relative to pre-contrast images. Both contrast agents were well tolerated.
Conclusion
Results showed a similar efficacy for Sonazoid™ and SonoVue® in diagnosing FLLs as benign or malignant, and underlined the benefit of CEUS imaging over unenhanced ultrasound imaging in reaching a confident diagnosis without having to refer patients for additional imaging exams.</description><subject>Confidence intervals</subject><subject>Contrast agents</subject><subject>Contrast media</subject><subject>Diagnostic systems</subject><subject>Gastroenterology</subject><subject>Hepatobiliary</subject><subject>Hepatology</subject><subject>Image contrast</subject><subject>Image enhancement</subject><subject>Imaging</subject><subject>Lesions</subject><subject>Liver</subject><subject>Medical diagnosis</subject><subject>Medical imaging</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Radiology</subject><subject>Safety</subject><subject>Statistical analysis</subject><subject>Ultrasonic imaging</subject><subject>Ultrasound</subject><issn>2366-004X</issn><issn>2366-0058</issn><issn>2366-0058</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kc9u1DAQxiMEolXpC3CyxIVLYPwvcS5IqKKAVAQSBXGzHO9k6yprLxmnaHkOnoOH4MlwdqsiOHCwPOP5zecZfVX1mMMzDtA-JwDR8BpEORI41PxedSxk09QA2ty_i9WXo-qU6BoAeKM5F_phdSQVl00nm-Pqx4cp0RZ9DjfIHBESbTBmlga2Cm4dE-XgGQ5D8M7vmIsrRm7AvFuIjym67ymsLt_tCyVNn2f89ZPNY54cpbk8-hSXODO3LrrEQmRbl8M-_hbyFRuSdyMby_8TG5FCivSoejC4kfD09j6pPp2_ujx7U1-8f_327OVF7aXhuXaIvZZK9MbrVveeezTQIXSgoR1ku1LOyd5I52XnlRmc6VQL0AvV9QI8lyfVi4Pudu43uPK4jDra7RQ2btrZ5IL9uxLDlV2nG2uU1FqIIvD0VmBKX2ekbDeBPI6ji5hmskKrYoPgqivok3_Q6zRPsaxXqJa3jeyMKZQ4UL7YQhMOd8NwsIvv9uC7Lb7bve92WUMemqjAcY3TH-n_dP0GsX2zAw</recordid><startdate>20211001</startdate><enddate>20211001</enddate><creator>Lv, Ke</creator><creator>Zhai, Hongyan</creator><creator>Jiang, Yuxin</creator><creator>Liang, Ping</creator><creator>Xu, Hui-Xiong</creator><creator>Du, Lianfang</creator><creator>Chou, Yi-Hong</creator><creator>Xie, Xiaoyan</creator><creator>Luo, YuKun</creator><creator>Lee, Young Joon</creator><creator>Lee, Jae Young</creator><creator>Hu, Bing</creator><creator>Luo, Baoming</creator><creator>Wang, Yi</creator><creator>Luan, Ying</creator><creator>Kalli, Christina</creator><creator>Chen, Kun</creator><creator>Wang, Wenping</creator><creator>Liang, Ja-Der</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>JQ2</scope><scope>K7-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>M7Z</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20211001</creationdate><title>Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions</title><author>Lv, Ke ; Zhai, Hongyan ; Jiang, Yuxin ; Liang, Ping ; Xu, Hui-Xiong ; Du, Lianfang ; Chou, Yi-Hong ; Xie, Xiaoyan ; Luo, YuKun ; Lee, Young Joon ; Lee, Jae Young ; Hu, Bing ; Luo, Baoming ; Wang, Yi ; Luan, Ying ; Kalli, Christina ; Chen, Kun ; Wang, Wenping ; Liang, Ja-Der</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c381t-aeeb5342b8c575bc1ce809e090507f37d4aa3b83ac39c48fa894700b249b20c13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Confidence intervals</topic><topic>Contrast agents</topic><topic>Contrast media</topic><topic>Diagnostic systems</topic><topic>Gastroenterology</topic><topic>Hepatobiliary</topic><topic>Hepatology</topic><topic>Image contrast</topic><topic>Image enhancement</topic><topic>Imaging</topic><topic>Lesions</topic><topic>Liver</topic><topic>Medical diagnosis</topic><topic>Medical imaging</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Radiology</topic><topic>Safety</topic><topic>Statistical analysis</topic><topic>Ultrasonic imaging</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lv, Ke</creatorcontrib><creatorcontrib>Zhai, Hongyan</creatorcontrib><creatorcontrib>Jiang, Yuxin</creatorcontrib><creatorcontrib>Liang, Ping</creatorcontrib><creatorcontrib>Xu, Hui-Xiong</creatorcontrib><creatorcontrib>Du, Lianfang</creatorcontrib><creatorcontrib>Chou, Yi-Hong</creatorcontrib><creatorcontrib>Xie, Xiaoyan</creatorcontrib><creatorcontrib>Luo, YuKun</creatorcontrib><creatorcontrib>Lee, Young Joon</creatorcontrib><creatorcontrib>Lee, Jae Young</creatorcontrib><creatorcontrib>Hu, Bing</creatorcontrib><creatorcontrib>Luo, Baoming</creatorcontrib><creatorcontrib>Wang, Yi</creatorcontrib><creatorcontrib>Luan, Ying</creatorcontrib><creatorcontrib>Kalli, Christina</creatorcontrib><creatorcontrib>Chen, Kun</creatorcontrib><creatorcontrib>Wang, Wenping</creatorcontrib><creatorcontrib>Liang, Ja-Der</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Abdominal imaging</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lv, Ke</au><au>Zhai, Hongyan</au><au>Jiang, Yuxin</au><au>Liang, Ping</au><au>Xu, Hui-Xiong</au><au>Du, Lianfang</au><au>Chou, Yi-Hong</au><au>Xie, Xiaoyan</au><au>Luo, YuKun</au><au>Lee, Young Joon</au><au>Lee, Jae Young</au><au>Hu, Bing</au><au>Luo, Baoming</au><au>Wang, Yi</au><au>Luan, Ying</au><au>Kalli, Christina</au><au>Chen, Kun</au><au>Wang, Wenping</au><au>Liang, Ja-Der</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions</atitle><jtitle>Abdominal imaging</jtitle><stitle>Abdom Radiol</stitle><date>2021-10-01</date><risdate>2021</risdate><volume>46</volume><issue>10</issue><spage>4647</spage><epage>4659</epage><pages>4647-4659</pages><issn>2366-004X</issn><issn>2366-0058</issn><eissn>2366-0058</eissn><abstract>Objectives
To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety.
Methods
This prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) (< 10 cm in diameter) underwent a contrast-enhanced ultrasound (CEUS) examination (218 received Sonazoid of 0.12 μL microbubbles/kg; 206 received SonoVue of 2.4 mL). Three independent blinded readers evaluated pre- and post-contrast images characterising the FLLs as benign or malignant.
Results
Sonazoid-enhanced and SonoVue-enhanced ultrasound provided a statistically significant improvement in specificity for all 3 readers comparing to unenhanced ultrasound (for Sonazoid:
p
= 0.0093, < 0.0001, 0.0011; for SonoVue:
p
= 0.002, 0.03, 0.12, respectively). Difference in accuracy improvement between the 2 groups was within the pre-specified non-inferiority margin of 20% for all 3 readers (6.1%, 95% CI: − 5.0 to 17.2; − 7.5%, 95% CI: − 18.4 to 3.5; − 0.3%, 95% CI: − 11.3 to 10.7).
The diagnostic confidence level for all 3 readers increased with post-contrast images relative to pre-contrast images. Both contrast agents were well tolerated.
Conclusion
Results showed a similar efficacy for Sonazoid™ and SonoVue® in diagnosing FLLs as benign or malignant, and underlined the benefit of CEUS imaging over unenhanced ultrasound imaging in reaching a confident diagnosis without having to refer patients for additional imaging exams.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>34136936</pmid><doi>10.1007/s00261-021-03010-1</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2366-004X |
| ispartof | Abdominal imaging, 2021-10, Vol.46 (10), p.4647-4659 |
| issn | 2366-004X 2366-0058 2366-0058 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8435522 |
| source | SpringerLink Journals - AutoHoldings |
| subjects | Confidence intervals Contrast agents Contrast media Diagnostic systems Gastroenterology Hepatobiliary Hepatology Image contrast Image enhancement Imaging Lesions Liver Medical diagnosis Medical imaging Medicine Medicine & Public Health Radiology Safety Statistical analysis Ultrasonic imaging Ultrasound |
| title | Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions |
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