Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial
The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividua...
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| Veröffentlicht in: | European radiology 2008-11, Vol.18 (11), p.2610-2619 |
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| creator | Tombach, Bernd Bohndorf, Klaus Brodtrager, Wolfgang Claussen, Claus D. Düber, Christoph Galanski, Michael Grabbe, Eckhardt Gortenuti, Giacomo Kuhn, Michael Gross-Fengels, Walter Hammerstingl, Renate Happel, Brigitte Heinz-Peer, Gertraud Jung, Gregor Kittner, Thomas Lagalla, Roberto Lengsfeld, Philipp Loose, Reinhard Oyen, Raymond H. G. Pavlica, Pietro Pering, Christiane Pozzi-Mucelli, Roberto Persigehl, Thorsten Reimer, Peter Renken, Nomdo S. Richter, Götz M. Rummeny, Ernst J. Schäfer, Fritz Szczerbo-Trojanowska, Malgorzata Urbanik, Andrzej Vogl, Thomas J. Hajek, Paul |
| description | The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers (‘average reader’) was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI. |
| doi_str_mv | 10.1007/s00330-008-1054-2 |
| format | Article |
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G. ; Pavlica, Pietro ; Pering, Christiane ; Pozzi-Mucelli, Roberto ; Persigehl, Thorsten ; Reimer, Peter ; Renken, Nomdo S. ; Richter, Götz M. ; Rummeny, Ernst J. ; Schäfer, Fritz ; Szczerbo-Trojanowska, Malgorzata ; Urbanik, Andrzej ; Vogl, Thomas J. ; Hajek, Paul</creator><creatorcontrib>Tombach, Bernd ; Bohndorf, Klaus ; Brodtrager, Wolfgang ; Claussen, Claus D. ; Düber, Christoph ; Galanski, Michael ; Grabbe, Eckhardt ; Gortenuti, Giacomo ; Kuhn, Michael ; Gross-Fengels, Walter ; Hammerstingl, Renate ; Happel, Brigitte ; Heinz-Peer, Gertraud ; Jung, Gregor ; Kittner, Thomas ; Lagalla, Roberto ; Lengsfeld, Philipp ; Loose, Reinhard ; Oyen, Raymond H. G. ; Pavlica, Pietro ; Pering, Christiane ; Pozzi-Mucelli, Roberto ; Persigehl, Thorsten ; Reimer, Peter ; Renken, Nomdo S. ; Richter, Götz M. ; Rummeny, Ernst J. ; Schäfer, Fritz ; Szczerbo-Trojanowska, Malgorzata ; Urbanik, Andrzej ; Vogl, Thomas J. ; Hajek, Paul</creatorcontrib><description>The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers (‘average reader’) was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.</description><identifier>ISSN: 0938-7994</identifier><identifier>EISSN: 1432-1084</identifier><identifier>DOI: 10.1007/s00330-008-1054-2</identifier><identifier>PMID: 18607594</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer-Verlag</publisher><subject>Contrast Media ; Diagnostic Radiology ; Europe - epidemiology ; Female ; Gadolinium DTPA - administration & dosage ; Humans ; Image Enhancement - methods ; Imaging ; Internal Medicine ; Interventional Radiology ; Kidney Neoplasms - diagnosis ; Kidney Neoplasms - epidemiology ; Magnetic Resonance ; Magnetic Resonance Imaging - methods ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Neuroradiology ; Organometallic Compounds - administration & dosage ; Radiology ; Reproducibility of Results ; Sensitivity and Specificity ; Single-Blind Method ; Ultrasound</subject><ispartof>European radiology, 2008-11, Vol.18 (11), p.2610-2619</ispartof><rights>The Author(s) 2008</rights><rights>European Society of Radiology 2008</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-3c0c7e40cef6ca9c433492b2070fc32cff6ca4853dba2a7e713c959f168da74d3</citedby><cites>FETCH-LOGICAL-c412t-3c0c7e40cef6ca9c433492b2070fc32cff6ca4853dba2a7e713c959f168da74d3</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/s00330-008-1054-2$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00330-008-1054-2$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>314,777,781,27905,27906,41469,42538,51300</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18607594$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tombach, Bernd</creatorcontrib><creatorcontrib>Bohndorf, Klaus</creatorcontrib><creatorcontrib>Brodtrager, Wolfgang</creatorcontrib><creatorcontrib>Claussen, Claus D.</creatorcontrib><creatorcontrib>Düber, Christoph</creatorcontrib><creatorcontrib>Galanski, Michael</creatorcontrib><creatorcontrib>Grabbe, Eckhardt</creatorcontrib><creatorcontrib>Gortenuti, Giacomo</creatorcontrib><creatorcontrib>Kuhn, Michael</creatorcontrib><creatorcontrib>Gross-Fengels, Walter</creatorcontrib><creatorcontrib>Hammerstingl, Renate</creatorcontrib><creatorcontrib>Happel, Brigitte</creatorcontrib><creatorcontrib>Heinz-Peer, Gertraud</creatorcontrib><creatorcontrib>Jung, Gregor</creatorcontrib><creatorcontrib>Kittner, Thomas</creatorcontrib><creatorcontrib>Lagalla, Roberto</creatorcontrib><creatorcontrib>Lengsfeld, Philipp</creatorcontrib><creatorcontrib>Loose, Reinhard</creatorcontrib><creatorcontrib>Oyen, Raymond H. G.</creatorcontrib><creatorcontrib>Pavlica, Pietro</creatorcontrib><creatorcontrib>Pering, Christiane</creatorcontrib><creatorcontrib>Pozzi-Mucelli, Roberto</creatorcontrib><creatorcontrib>Persigehl, Thorsten</creatorcontrib><creatorcontrib>Reimer, Peter</creatorcontrib><creatorcontrib>Renken, Nomdo S.</creatorcontrib><creatorcontrib>Richter, Götz M.</creatorcontrib><creatorcontrib>Rummeny, Ernst J.</creatorcontrib><creatorcontrib>Schäfer, Fritz</creatorcontrib><creatorcontrib>Szczerbo-Trojanowska, Malgorzata</creatorcontrib><creatorcontrib>Urbanik, Andrzej</creatorcontrib><creatorcontrib>Vogl, Thomas J.</creatorcontrib><creatorcontrib>Hajek, Paul</creatorcontrib><title>Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial</title><title>European radiology</title><addtitle>Eur Radiol</addtitle><addtitle>Eur Radiol</addtitle><description>The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers (‘average reader’) was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. 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G.</creatorcontrib><creatorcontrib>Pavlica, Pietro</creatorcontrib><creatorcontrib>Pering, Christiane</creatorcontrib><creatorcontrib>Pozzi-Mucelli, Roberto</creatorcontrib><creatorcontrib>Persigehl, Thorsten</creatorcontrib><creatorcontrib>Reimer, Peter</creatorcontrib><creatorcontrib>Renken, Nomdo S.</creatorcontrib><creatorcontrib>Richter, Götz M.</creatorcontrib><creatorcontrib>Rummeny, Ernst J.</creatorcontrib><creatorcontrib>Schäfer, Fritz</creatorcontrib><creatorcontrib>Szczerbo-Trojanowska, Malgorzata</creatorcontrib><creatorcontrib>Urbanik, Andrzej</creatorcontrib><creatorcontrib>Vogl, Thomas J.</creatorcontrib><creatorcontrib>Hajek, Paul</creatorcontrib><collection>SpringerOpen</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>ProQuest Nursing and Allied Health Source</collection><collection>ProQuest Health and Medical</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 Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>Advanced Technologies & Aerospace Database (1962 - current)</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest Biological Science Journals</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest advanced technologies & aerospace journals</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>European radiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tombach, Bernd</au><au>Bohndorf, Klaus</au><au>Brodtrager, Wolfgang</au><au>Claussen, Claus D.</au><au>Düber, Christoph</au><au>Galanski, Michael</au><au>Grabbe, Eckhardt</au><au>Gortenuti, Giacomo</au><au>Kuhn, Michael</au><au>Gross-Fengels, Walter</au><au>Hammerstingl, Renate</au><au>Happel, Brigitte</au><au>Heinz-Peer, Gertraud</au><au>Jung, Gregor</au><au>Kittner, Thomas</au><au>Lagalla, Roberto</au><au>Lengsfeld, Philipp</au><au>Loose, Reinhard</au><au>Oyen, Raymond H. G.</au><au>Pavlica, Pietro</au><au>Pering, Christiane</au><au>Pozzi-Mucelli, Roberto</au><au>Persigehl, Thorsten</au><au>Reimer, Peter</au><au>Renken, Nomdo S.</au><au>Richter, Götz M.</au><au>Rummeny, Ernst J.</au><au>Schäfer, Fritz</au><au>Szczerbo-Trojanowska, Malgorzata</au><au>Urbanik, Andrzej</au><au>Vogl, Thomas J.</au><au>Hajek, Paul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial</atitle><jtitle>European radiology</jtitle><stitle>Eur Radiol</stitle><addtitle>Eur Radiol</addtitle><date>2008-11-01</date><risdate>2008</risdate><volume>18</volume><issue>11</issue><spage>2610</spage><epage>2619</epage><pages>2610-2619</pages><issn>0938-7994</issn><eissn>1432-1084</eissn><abstract>The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers (‘average reader’) was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer-Verlag</pub><pmid>18607594</pmid><doi>10.1007/s00330-008-1054-2</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0938-7994 |
| ispartof | European radiology, 2008-11, Vol.18 (11), p.2610-2619 |
| issn | 0938-7994 1432-1084 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_69648301 |
| source | MEDLINE; Springer journals |
| subjects | Contrast Media Diagnostic Radiology Europe - epidemiology Female Gadolinium DTPA - administration & dosage Humans Image Enhancement - methods Imaging Internal Medicine Interventional Radiology Kidney Neoplasms - diagnosis Kidney Neoplasms - epidemiology Magnetic Resonance Magnetic Resonance Imaging - methods Male Medicine Medicine & Public Health Middle Aged Neuroradiology Organometallic Compounds - administration & dosage Radiology Reproducibility of Results Sensitivity and Specificity Single-Blind Method Ultrasound |
| title | Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-17T17%3A49%3A44IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Comparison%20of%201.0%C2%A0M%20gadobutrol%20and%200.5%C2%A0M%20gadopentate%20dimeglumine-enhanced%20MRI%20in%20471%20patients%20with%20known%20or%20suspected%20renal%20lesions:%20results%20of%20a%20multicenter,%20single-blind,%20interindividual,%20randomized%20clinical%20phase%20III%20trial&rft.jtitle=European%20radiology&rft.au=Tombach,%20Bernd&rft.date=2008-11-01&rft.volume=18&rft.issue=11&rft.spage=2610&rft.epage=2619&rft.pages=2610-2619&rft.issn=0938-7994&rft.eissn=1432-1084&rft_id=info:doi/10.1007/s00330-008-1054-2&rft_dat=%3Cproquest_cross%3E1898271561%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=218922284&rft_id=info:pmid/18607594&rfr_iscdi=true |