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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<series><title level="j" type="main">European journal of radiology</title>
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<idno type="ISSN">0720-048X</idno>
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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>
</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>
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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>
</front>
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<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>
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