A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease
Identifieur interne : 003460 ( PascalFrancis/Checkpoint ); précédent : 003459; suivant : 003461A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease
Auteurs : Robert Mcgregor [Canada] ; Josef Vymazal [République tchèque] ; Manuel Martinez-Lopez [Mexique] ; Jiri Neuwirth [République tchèque] ; Perla Salgado [Mexique] ; Jean-Paul Beregi [France] ; Anthony Peduto [Australie] ; Erasmo De La Pena-Almaguer [Mexique] ; Greg J. Slater [Australie] ; Kohkan Shamsi [États-Unis] ; Edward C. Jr Parsons [États-Unis]Source :
- European journal of radiology [ 0720-048X ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Purpose: To determine prospectively the safety and efficacy of the blood-pool contrast agent gadofosveset trisodium in renal artery magnetic resonance angiography (MRA). Materials and methods: Gadofosveset (0.03 mmol/kg) was administered to adult patients with known or suspected renal arterial disease in a multi-center phase 3 single dose study. The drug binds reversibly to albumin, prolonging the blood residence time, and allowing collection of images in the first-pass and steady-state phases. The combination of these images was compared to non-contrast MRA, using catheter X-ray angiography (XRA) as the standard of reference (SOR). All MRA images were collected at 1.5 T in one imaging session for direct comparison, and XRA within 30 days. Sensitivity, specificity, and accuracy for diagnosing significant disease (stenosis ≥50%) were calculated for MRA using three independent blinded readers. Patient safety was monitored for 72-96 h. Results: A total of 145 patients at 18 centers were enrolled and received gadofosveset; the 127 with complete efficacy data entered the primary efficacy analysis. Gadofosveset-enhanced MRA led to significant improvement (p<0.01) in sensitivity (+25%, +26%, +42%), specificity (+23%, +25%, +29%), and accuracy (+23%, +28%, +29%) over non-enhanced MRA for the three readers. The rate of uninterpretable examinations decreased from 30% to less than 2%. There were no serious adverse events, and the most common adverse events were nausea, pruritis, and headache (8% each). No significant trends in clinical chemistry parameters, nor significant changes in serum creatinine, were found following administration of gadofosveset. Conclusion: In patients with known or suspected renal arterial disease, multi-phase gadofosveset-enhanced MRA significantly improves sensitivity, specificity, and accuracy versus non-enhanced MRA. Gadofosveset was safe and well tolerated in this patient population.
Affiliations:
- Australie, Canada, France, Mexique, République tchèque, États-Unis
- Bohême centrale, Hauts-de-France, Nord-Pas-de-Calais
- Lille, Prague
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease</title><author><name sortKey="Mcgregor, Robert" sort="Mcgregor, Robert" uniqKey="Mcgregor R" first="Robert" last="Mcgregor">Robert Mcgregor</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>St. Boniface Général Hospital</s1><s2>Winnipeg, Manitoba</s2><s3>CAN</s3><sZ>1 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>St. Boniface Général Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Vymazal, Josef" sort="Vymazal, Josef" uniqKey="Vymazal J" first="Josef" last="Vymazal">Josef Vymazal</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Hospital Na Homolce</s1><s2>Prague</s2><s3>CZE</s3><sZ>2 aut.</sZ></inist:fA14><country>République tchèque</country><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Martinez Lopez, Manuel" sort="Martinez Lopez, Manuel" uniqKey="Martinez Lopez M" first="Manuel" last="Martinez-Lopez">Manuel Martinez-Lopez</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Hospital Medica Sur</s1><s2>Mexico City</s2><s3>MEX</s3><sZ>3 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Hospital Medica Sur</wicri:noRegion></affiliation></author><author><name sortKey="Neuwirth, Jiri" sort="Neuwirth, Jiri" uniqKey="Neuwirth J" first="Jiri" last="Neuwirth">Jiri Neuwirth</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Faculty Hospital Motol</s1><s2>Prague</s2><s3>CZE</s3><sZ>4 aut.</sZ></inist:fA14><country>République tchèque</country><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Salgado, Perla" sort="Salgado, Perla" uniqKey="Salgado P" first="Perla" last="Salgado">Perla Salgado</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>American British Cowdray Medical Center</s1><s2>Mexico City</s2><s3>MEX</s3><sZ>5 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>American British Cowdray Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Beregi, Jean Paul" sort="Beregi, Jean Paul" uniqKey="Beregi J" first="Jean-Paul" last="Beregi">Jean-Paul Beregi</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Hôpital Cardiologique</s1><s2>Lille</s2><s3>FRA</s3><sZ>6 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Peduto, Anthony" sort="Peduto, Anthony" uniqKey="Peduto A" first="Anthony" last="Peduto">Anthony Peduto</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Westmead Hospital</s1><s2>Westmead New South Wales</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Westmead Hospital</wicri:noRegion></affiliation></author><author><name sortKey="De La Pena Almaguer, Erasmo" sort="De La Pena Almaguer, Erasmo" uniqKey="De La Pena Almaguer E" first="Erasmo" last="De La Pena-Almaguer">Erasmo De La Pena-Almaguer</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Christus-Muguerza Medical Center</s1><s2>Monterrey, Nuevo Léon</s2><s3>MEX</s3><sZ>8 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Christus-Muguerza Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Slater, Greg J" sort="Slater, Greg J" uniqKey="Slater G" first="Greg J." last="Slater">Greg J. Slater</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Greenslopes Private Hospital</s1><s2>Greenslopes, Queensland</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Greenslopes Private Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Shamsi, Kohkan" sort="Shamsi, Kohkan" uniqKey="Shamsi K" first="Kohkan" last="Shamsi">Kohkan Shamsi</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Berlex Laboratories</s1><s2>Montville, NJ</s2><s3>USA</s3><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Berlex Laboratories</wicri:noRegion></affiliation></author><author><name sortKey="Parsons, Edward C Jr" sort="Parsons, Edward C Jr" uniqKey="Parsons E" first="Edward C. Jr" last="Parsons">Edward C. Jr Parsons</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>EPIX Pharmaceuticals, Inc</s1><s2>Lexington, MA</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Lexington, MA</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">08-0139515</idno><date when="2008">2008</date><idno type="stanalyst">PASCAL 08-0139515 INIST</idno><idno type="RBID">Pascal:08-0139515</idno><idno type="wicri:Area/PascalFrancis/Corpus">003701</idno><idno type="wicri:Area/PascalFrancis/Curation">002938</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">003460</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">003460</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease</title><author><name sortKey="Mcgregor, Robert" sort="Mcgregor, Robert" uniqKey="Mcgregor R" first="Robert" last="Mcgregor">Robert Mcgregor</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>St. Boniface Général Hospital</s1><s2>Winnipeg, Manitoba</s2><s3>CAN</s3><sZ>1 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>St. Boniface Général Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Vymazal, Josef" sort="Vymazal, Josef" uniqKey="Vymazal J" first="Josef" last="Vymazal">Josef Vymazal</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Hospital Na Homolce</s1><s2>Prague</s2><s3>CZE</s3><sZ>2 aut.</sZ></inist:fA14><country>République tchèque</country><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Martinez Lopez, Manuel" sort="Martinez Lopez, Manuel" uniqKey="Martinez Lopez M" first="Manuel" last="Martinez-Lopez">Manuel Martinez-Lopez</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Hospital Medica Sur</s1><s2>Mexico City</s2><s3>MEX</s3><sZ>3 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Hospital Medica Sur</wicri:noRegion></affiliation></author><author><name sortKey="Neuwirth, Jiri" sort="Neuwirth, Jiri" uniqKey="Neuwirth J" first="Jiri" last="Neuwirth">Jiri Neuwirth</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Faculty Hospital Motol</s1><s2>Prague</s2><s3>CZE</s3><sZ>4 aut.</sZ></inist:fA14><country>République tchèque</country><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Salgado, Perla" sort="Salgado, Perla" uniqKey="Salgado P" first="Perla" last="Salgado">Perla Salgado</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>American British Cowdray Medical Center</s1><s2>Mexico City</s2><s3>MEX</s3><sZ>5 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>American British Cowdray Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Beregi, Jean Paul" sort="Beregi, Jean Paul" uniqKey="Beregi J" first="Jean-Paul" last="Beregi">Jean-Paul Beregi</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Hôpital Cardiologique</s1><s2>Lille</s2><s3>FRA</s3><sZ>6 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Peduto, Anthony" sort="Peduto, Anthony" uniqKey="Peduto A" first="Anthony" last="Peduto">Anthony Peduto</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Westmead Hospital</s1><s2>Westmead New South Wales</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Westmead Hospital</wicri:noRegion></affiliation></author><author><name sortKey="De La Pena Almaguer, Erasmo" sort="De La Pena Almaguer, Erasmo" uniqKey="De La Pena Almaguer E" first="Erasmo" last="De La Pena-Almaguer">Erasmo De La Pena-Almaguer</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Christus-Muguerza Medical Center</s1><s2>Monterrey, Nuevo Léon</s2><s3>MEX</s3><sZ>8 aut.</sZ></inist:fA14><country>Mexique</country><wicri:noRegion>Christus-Muguerza Medical Center</wicri:noRegion></affiliation></author><author><name sortKey="Slater, Greg J" sort="Slater, Greg J" uniqKey="Slater G" first="Greg J." last="Slater">Greg J. Slater</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Greenslopes Private Hospital</s1><s2>Greenslopes, Queensland</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Greenslopes Private Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Shamsi, Kohkan" sort="Shamsi, Kohkan" uniqKey="Shamsi K" first="Kohkan" last="Shamsi">Kohkan Shamsi</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Berlex Laboratories</s1><s2>Montville, NJ</s2><s3>USA</s3><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Berlex Laboratories</wicri:noRegion></affiliation></author><author><name sortKey="Parsons, Edward C Jr" sort="Parsons, Edward C Jr" uniqKey="Parsons E" first="Edward C. Jr" last="Parsons">Edward C. Jr Parsons</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>EPIX Pharmaceuticals, Inc</s1><s2>Lexington, MA</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Lexington, MA</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">European journal of radiology</title><title level="j" type="abbreviated">Eur. j. radiol.</title><idno type="ISSN">0720-048X</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">European journal of radiology</title><title level="j" type="abbreviated">Eur. j. radiol.</title><idno type="ISSN">0720-048X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Comparative study</term><term>Contrast media</term><term>Diagnostic agent</term><term>Gadofosveset</term><term>NMR angiography</term><term>Nuclear magnetic resonance imaging</term><term>Radiology</term><term>Renal artery</term><term>Renal artery disease</term><term>Renal artery stenosis</term><term>Vascular disease</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Pathologie de l'artère rénale</term><term>Pathologie des vaisseaux sanguins</term><term>Sténose de l'artère rénale</term><term>Gadofosvéset</term><term>Angiographie RMN</term><term>Radiologie</term><term>Etude comparative</term><term>Produit contraste</term><term>Imagerie RMN</term><term>Artère rénale</term><term>Produit diagnostic</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose: To determine prospectively the safety and efficacy of the blood-pool contrast agent gadofosveset trisodium in renal artery magnetic resonance angiography (MRA). Materials and methods: Gadofosveset (0.03 mmol/kg) was administered to adult patients with known or suspected renal arterial disease in a multi-center phase 3 single dose study. The drug binds reversibly to albumin, prolonging the blood residence time, and allowing collection of images in the first-pass and steady-state phases. The combination of these images was compared to non-contrast MRA, using catheter X-ray angiography (XRA) as the standard of reference (SOR). All MRA images were collected at 1.5 T in one imaging session for direct comparison, and XRA within 30 days. Sensitivity, specificity, and accuracy for diagnosing significant disease (stenosis ≥50%) were calculated for MRA using three independent blinded readers. Patient safety was monitored for 72-96 h. Results: A total of 145 patients at 18 centers were enrolled and received gadofosveset; the 127 with complete efficacy data entered the primary efficacy analysis. Gadofosveset-enhanced MRA led to significant improvement (p<0.01) in sensitivity (+25%, +26%, +42%), specificity (+23%, +25%, +29%), and accuracy (+23%, +28%, +29%) over non-enhanced MRA for the three readers. The rate of uninterpretable examinations decreased from 30% to less than 2%. There were no serious adverse events, and the most common adverse events were nausea, pruritis, and headache (8% each). No significant trends in clinical chemistry parameters, nor significant changes in serum creatinine, were found following administration of gadofosveset. Conclusion: In patients with known or suspected renal arterial disease, multi-phase gadofosveset-enhanced MRA significantly improves sensitivity, specificity, and accuracy versus non-enhanced MRA. Gadofosveset was safe and well tolerated in this patient population.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0720-048X</s0></fA01><fA02 i1="01"><s0>EJRADR</s0></fA02><fA03 i2="1"><s0>Eur. j. radiol.</s0></fA03><fA05><s2>65</s2></fA05><fA06><s2>2</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease</s1></fA08><fA11 i1="01" i2="1"><s1>MCGREGOR (Robert)</s1></fA11><fA11 i1="02" i2="1"><s1>VYMAZAL (Josef)</s1></fA11><fA11 i1="03" i2="1"><s1>MARTINEZ-LOPEZ (Manuel)</s1></fA11><fA11 i1="04" i2="1"><s1>NEUWIRTH (Jiri)</s1></fA11><fA11 i1="05" i2="1"><s1>SALGADO (Perla)</s1></fA11><fA11 i1="06" i2="1"><s1>BEREGI (Jean-Paul)</s1></fA11><fA11 i1="07" i2="1"><s1>PEDUTO (Anthony)</s1></fA11><fA11 i1="08" i2="1"><s1>DE LA PENA-ALMAGUER (Erasmo)</s1></fA11><fA11 i1="09" i2="1"><s1>SLATER (Greg J.)</s1></fA11><fA11 i1="10" i2="1"><s1>SHAMSI (Kohkan)</s1></fA11><fA11 i1="11" i2="1"><s1>PARSONS (Edward C. JR)</s1></fA11><fA14 i1="01"><s1>St. Boniface Général Hospital</s1><s2>Winnipeg, Manitoba</s2><s3>CAN</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Hospital Na Homolce</s1><s2>Prague</s2><s3>CZE</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Hospital Medica Sur</s1><s2>Mexico City</s2><s3>MEX</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Faculty Hospital Motol</s1><s2>Prague</s2><s3>CZE</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>American British Cowdray Medical Center</s1><s2>Mexico City</s2><s3>MEX</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Hôpital Cardiologique</s1><s2>Lille</s2><s3>FRA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Westmead Hospital</s1><s2>Westmead New South Wales</s2><s3>AUS</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>Christus-Muguerza Medical Center</s1><s2>Monterrey, Nuevo Léon</s2><s3>MEX</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Greenslopes Private Hospital</s1><s2>Greenslopes, Queensland</s2><s3>AUS</s3><sZ>9 aut.</sZ></fA14><fA14 i1="10"><s1>Berlex Laboratories</s1><s2>Montville, NJ</s2><s3>USA</s3><sZ>10 aut.</sZ></fA14><fA14 i1="11"><s1>EPIX Pharmaceuticals, Inc</s1><s2>Lexington, MA</s2><s3>USA</s3><sZ>11 aut.</sZ></fA14><fA20><s1>316-325</s1></fA20><fA21><s1>2008</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>18731</s2><s5>354000175091500210</s5></fA43><fA44><s0>0000</s0><s1>© 2008 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>26 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>08-0139515</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>European journal of radiology</s0></fA64><fA66 i1="01"><s0>IRL</s0></fA66><fC01 i1="01" l="ENG"><s0>Purpose: To determine prospectively the safety and efficacy of the blood-pool contrast agent gadofosveset trisodium in renal artery magnetic resonance angiography (MRA). Materials and methods: Gadofosveset (0.03 mmol/kg) was administered to adult patients with known or suspected renal arterial disease in a multi-center phase 3 single dose study. The drug binds reversibly to albumin, prolonging the blood residence time, and allowing collection of images in the first-pass and steady-state phases. The combination of these images was compared to non-contrast MRA, using catheter X-ray angiography (XRA) as the standard of reference (SOR). All MRA images were collected at 1.5 T in one imaging session for direct comparison, and XRA within 30 days. Sensitivity, specificity, and accuracy for diagnosing significant disease (stenosis ≥50%) were calculated for MRA using three independent blinded readers. Patient safety was monitored for 72-96 h. Results: A total of 145 patients at 18 centers were enrolled and received gadofosveset; the 127 with complete efficacy data entered the primary efficacy analysis. Gadofosveset-enhanced MRA led to significant improvement (p<0.01) in sensitivity (+25%, +26%, +42%), specificity (+23%, +25%, +29%), and accuracy (+23%, +28%, +29%) over non-enhanced MRA for the three readers. The rate of uninterpretable examinations decreased from 30% to less than 2%. There were no serious adverse events, and the most common adverse events were nausea, pruritis, and headache (8% each). No significant trends in clinical chemistry parameters, nor significant changes in serum creatinine, were found following administration of gadofosveset. Conclusion: In patients with known or suspected renal arterial disease, multi-phase gadofosveset-enhanced MRA significantly improves sensitivity, specificity, and accuracy versus non-enhanced MRA. Gadofosveset was safe and well tolerated in this patient population.</s0></fC01><fC02 i1="01" i2="X"><s0>002B24A03</s0></fC02><fC02 i1="02" i2="X"><s0>002B14A04</s0></fC02><fC02 i1="03" i2="X"><s0>002B14E01</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Pathologie de l'artère rénale</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Renal artery disease</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Arteria renal patología</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Pathologie des vaisseaux sanguins</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Vascular disease</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Vaso sanguíneo patología</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Sténose de l'artère rénale</s0><s2>NM</s2><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Renal artery stenosis</s0><s2>NM</s2><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Estenosis arteria renal</s0><s2>NM</s2><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Gadofosvéset</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Gadofosveset</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Gadofosveset</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Angiographie RMN</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>NMR angiography</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Angiografía RMN</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Radiologie</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Radiology</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Radiología</s0><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Etude comparative</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Comparative study</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>07</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Produit contraste</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Contrast media</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Medio contraste</s0><s5>08</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Imagerie RMN</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Nuclear magnetic resonance imaging</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Imaginería RMN</s0><s5>09</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Artère rénale</s0><s5>13</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Renal artery</s0><s5>13</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Arteria renal</s0><s5>13</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Produit diagnostic</s0><s5>30</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Diagnostic agent</s0><s5>30</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Producto diagnóstico</s0><s5>30</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Imagerie médicale</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Medical imagery</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Imaginería médica</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Pathologie de l'appareil circulatoire</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Cardiovascular disease</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Aparato circulatorio patología</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Pathologie de l'appareil urinaire</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Urinary system disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Aparato urinario patología</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Pathologie des artères</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Arterial disease</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Arteria patología</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Pathologie du rein</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Kidney disease</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Riñón patología</s0><s5>41</s5></fC07><fN21><s1>084</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li><li>Mexique</li><li>République tchèque</li><li>États-Unis</li></country><region><li>Bohême centrale</li><li>Hauts-de-France</li><li>Nord-Pas-de-Calais</li></region><settlement><li>Lille</li><li>Prague</li></settlement></list><tree><country name="Canada"><noRegion><name sortKey="Mcgregor, Robert" sort="Mcgregor, Robert" uniqKey="Mcgregor R" first="Robert" last="Mcgregor">Robert Mcgregor</name></noRegion></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Vymazal, Josef" sort="Vymazal, Josef" uniqKey="Vymazal J" first="Josef" last="Vymazal">Josef Vymazal</name></region><name sortKey="Neuwirth, Jiri" sort="Neuwirth, Jiri" uniqKey="Neuwirth J" first="Jiri" last="Neuwirth">Jiri Neuwirth</name></country><country name="Mexique"><noRegion><name sortKey="Martinez Lopez, Manuel" sort="Martinez Lopez, Manuel" uniqKey="Martinez Lopez M" first="Manuel" last="Martinez-Lopez">Manuel Martinez-Lopez</name></noRegion><name sortKey="De La Pena Almaguer, Erasmo" sort="De La Pena Almaguer, Erasmo" uniqKey="De La Pena Almaguer E" first="Erasmo" last="De La Pena-Almaguer">Erasmo De La Pena-Almaguer</name><name sortKey="Salgado, Perla" sort="Salgado, Perla" uniqKey="Salgado P" first="Perla" last="Salgado">Perla Salgado</name></country><country name="France"><region name="Hauts-de-France"><name sortKey="Beregi, Jean Paul" sort="Beregi, Jean Paul" uniqKey="Beregi J" first="Jean-Paul" last="Beregi">Jean-Paul Beregi</name></region></country><country name="Australie"><noRegion><name sortKey="Peduto, Anthony" sort="Peduto, Anthony" uniqKey="Peduto A" first="Anthony" last="Peduto">Anthony Peduto</name></noRegion><name sortKey="Slater, Greg J" sort="Slater, Greg J" uniqKey="Slater G" first="Greg J." last="Slater">Greg J. Slater</name></country><country name="États-Unis"><noRegion><name sortKey="Shamsi, Kohkan" sort="Shamsi, Kohkan" uniqKey="Shamsi K" first="Kohkan" last="Shamsi">Kohkan Shamsi</name></noRegion><name sortKey="Parsons, Edward C Jr" sort="Parsons, Edward C Jr" uniqKey="Parsons E" first="Edward C. Jr" last="Parsons">Edward C. Jr Parsons</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease
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