AustralieFrV1, PascalFrancis, Corpus, bibRecord, 003701

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 : 003701 ( PascalFrancis/Corpus ); précédent : 003700; suivant : 003702

A 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 ; Josef Vymazal ; Manuel Martinez-Lopez ; Jiri Neuwirth ; Perla Salgado ; Jean-Paul Beregi ; Anthony Peduto ; Erasmo De La Pena-Almaguer ; Greg J. Slater ; Kohkan Shamsi ; Edward C. Jr Parsons

Source :

European journal of radiology [ 0720-048X ] ; 2008.

RBID : Pascal:08-0139515

Descripteurs français

Pascal (Inist)
- Pathologie de l'artère rénale, Pathologie des vaisseaux sanguins, Sténose de l'artère rénale, Gadofosvéset, Angiographie RMN, Radiologie, Etude comparative, Produit contraste, Imagerie RMN, Artère rénale, Produit diagnostic.

English descriptors

KwdEn :
- Comparative study, Contrast media, Diagnostic agent, Gadofosveset, NMR angiography, Nuclear magnetic resonance imaging, Radiology, Renal artery, Renal artery disease, Renal artery stenosis, Vascular disease.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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C01	`01`		`ENG`	@0 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.
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C03	`05`	`X`	`ENG`	`@0 NMR angiography @5 05`
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Format Inist (serveur)

NO :	PASCAL 08-0139515 INIST
ET :	A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease
AU :	MCGREGOR (Robert); VYMAZAL (Josef); MARTINEZ-LOPEZ (Manuel); NEUWIRTH (Jiri); SALGADO (Perla); BEREGI (Jean-Paul); PEDUTO (Anthony); DE LA PENA-ALMAGUER (Erasmo); SLATER (Greg J.); SHAMSI (Kohkan); PARSONS (Edward C. JR)
AF :	St. Boniface Général Hospital/Winnipeg, Manitoba/Canada (1 aut.); Hospital Na Homolce/Prague/Tchèque, République (2 aut.); Hospital Medica Sur/Mexico City/Mexique (3 aut.); Faculty Hospital Motol/Prague/Tchèque, République (4 aut.); American British Cowdray Medical Center/Mexico City/Mexique (5 aut.); Hôpital Cardiologique/Lille/France (6 aut.); Westmead Hospital/Westmead New South Wales/Australie (7 aut.); Christus-Muguerza Medical Center/Monterrey, Nuevo Léon/Mexique (8 aut.); Greenslopes Private Hospital/Greenslopes, Queensland/Australie (9 aut.); Berlex Laboratories/Montville, NJ/Etats-Unis (10 aut.); EPIX Pharmaceuticals, Inc/Lexington, MA/Etats-Unis (11 aut.)
DT :	Publication en série; Niveau analytique
SO :	European journal of radiology; ISSN 0720-048X; Coden EJRADR; Irlande; Da. 2008; Vol. 65; No. 2; Pp. 316-325; Bibl. 26 ref.
LA :	Anglais
EA :	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.
CC :	002B24A03; 002B14A04; 002B14E01
FD :	Pathologie de l'artère rénale; Pathologie des vaisseaux sanguins; Sténose de l'artère rénale; Gadofosvéset; Angiographie RMN; Radiologie; Etude comparative; Produit contraste; Imagerie RMN; Artère rénale; Produit diagnostic
FG :	Imagerie médicale; Pathologie de l'appareil circulatoire; Pathologie de l'appareil urinaire; Pathologie des artères; Pathologie du rein
ED :	Renal artery disease; Vascular disease; Renal artery stenosis; Gadofosveset; NMR angiography; Radiology; Comparative study; Contrast media; Nuclear magnetic resonance imaging; Renal artery; Diagnostic agent
EG :	Medical imagery; Cardiovascular disease; Urinary system disease; Arterial disease; Kidney disease
SD :	Arteria renal patología; Vaso sanguíneo patología; Estenosis arteria renal; Gadofosveset; Angiografía RMN; Radiología; Estudio comparativo; Medio contraste; Imaginería RMN; Arteria renal; Producto diagnóstico
LO :	INIST-18731.354000175091500210
ID :	08-0139515

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Pascal:08-0139515

Le document en format XML

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<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>
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<author><name sortKey="Salgado, Perla" sort="Salgado, Perla" uniqKey="Salgado P" first="Perla" last="Salgado">Perla Salgado</name>
<affiliation><inist:fA14 i1="05"><s1>American British Cowdray Medical Center</s1>
<s2>Mexico City</s2>
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<author><name sortKey="Beregi, Jean Paul" sort="Beregi, Jean Paul" uniqKey="Beregi J" first="Jean-Paul" last="Beregi">Jean-Paul Beregi</name>
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<author><name sortKey="Peduto, Anthony" sort="Peduto, Anthony" uniqKey="Peduto A" first="Anthony" last="Peduto">Anthony Peduto</name>
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<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>
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<author><name sortKey="Slater, Greg J" sort="Slater, Greg J" uniqKey="Slater G" first="Greg J." last="Slater">Greg J. Slater</name>
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<series><title level="j" type="main">European journal of radiology</title>
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<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>
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<term>Sténose de l'artère rénale</term>
<term>Gadofosvéset</term>
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<term>Radiologie</term>
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<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>
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<ET>A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease</ET>
<AU>MCGREGOR (Robert); VYMAZAL (Josef); MARTINEZ-LOPEZ (Manuel); NEUWIRTH (Jiri); SALGADO (Perla); BEREGI (Jean-Paul); PEDUTO (Anthony); DE LA PENA-ALMAGUER (Erasmo); SLATER (Greg J.); SHAMSI (Kohkan); PARSONS (Edward C. JR)</AU>
<AF>St. Boniface Général Hospital/Winnipeg, Manitoba/Canada (1 aut.); Hospital Na Homolce/Prague/Tchèque, République (2 aut.); Hospital Medica Sur/Mexico City/Mexique (3 aut.); Faculty Hospital Motol/Prague/Tchèque, République (4 aut.); American British Cowdray Medical Center/Mexico City/Mexique (5 aut.); Hôpital Cardiologique/Lille/France (6 aut.); Westmead Hospital/Westmead New South Wales/Australie (7 aut.); Christus-Muguerza Medical Center/Monterrey, Nuevo Léon/Mexique (8 aut.); Greenslopes Private Hospital/Greenslopes, Queensland/Australie (9 aut.); Berlex Laboratories/Montville, NJ/Etats-Unis (10 aut.); EPIX Pharmaceuticals, Inc/Lexington, MA/Etats-Unis (11 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>European journal of radiology; ISSN 0720-048X; Coden EJRADR; Irlande; Da. 2008; Vol. 65; No. 2; Pp. 316-325; Bibl. 26 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B24A03; 002B14A04; 002B14E01</CC>
<FD>Pathologie de l'artère rénale; Pathologie des vaisseaux sanguins; Sténose de l'artère rénale; Gadofosvéset; Angiographie RMN; Radiologie; Etude comparative; Produit contraste; Imagerie RMN; Artère rénale; Produit diagnostic</FD>
<FG>Imagerie médicale; Pathologie de l'appareil circulatoire; Pathologie de l'appareil urinaire; Pathologie des artères; Pathologie du rein</FG>
<ED>Renal artery disease; Vascular disease; Renal artery stenosis; Gadofosveset; NMR angiography; Radiology; Comparative study; Contrast media; Nuclear magnetic resonance imaging; Renal artery; Diagnostic agent</ED>
<EG>Medical imagery; Cardiovascular disease; Urinary system disease; Arterial disease; Kidney disease</EG>
<SD>Arteria renal patología; Vaso sanguíneo patología; Estenosis arteria renal; Gadofosveset; Angiografía RMN; Radiología; Estudio comparativo; Medio contraste; Imaginería RMN; Arteria renal; Producto diagnóstico</SD>
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A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease

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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