Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): A phase II study

Thomas Kittner, Jens Rudolf, Joan Falco Fages, Paul Legmann, Manuela Aschauer, I. Repa, Marta Rodriguez Alvares, Ibone Savalegui, Harald Ittrich, Kjell Geterud, Eric de Kevviler, Juan Ayuso, Mark E. Lockhart, Alain Blum, Herbert Iliasch, Gerda Leisinger, E. J R van Beek, Allan W. Reid, Jeffrey J. Brown, Thomas C. YuScott D. Flamm, Christoph Düber, Werner Judmaier, Peter Reimer, Michael Stiskal, Bernhard Kramann, Steve Wolff, Christiane Blankenstein

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: To determine the most efficacious dose of gadodiamide for three-dimensional (3D) contrast-enhanced (CE) magnetic resonance angiography (MRA) of the renal arteries on a patient level based on the sensitivity in detecting the main hemodynamically relevant (≥50% or occlusion) renal artery stenosis (RAS) using intra-arterial digital subtraction angiography (IA DSA) as the gold standard. Materials and Methods: This prospective, randomized, double-blind, parallel-group, multicenter study included 273 patients referred to IA DSA for suspected RAS. Patients underwent 3D CE MRA after injection of 0.01, 0.05, 0.1, or 0.2 mmol/kg of body weight gadodiamide (0.5 mmol/ml). The images were assessed for location and degree of RAS by independent blinded readers (MRA: three readers, IA DSA: one reader). Hypothesis testing for a significant trend in sensitivity across dose groups was based on the one-sided Cochran-Armitage style trend test for each independent MRA reader. Results: The lowest dose group (0.01 mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., ≥50% or occlusion) RAS. A statistically significant dose trend (p <0.001) was shown for each of the three independent readers. Depending on reader, the sensitivity obtained with 0.05, 0.1, and 0.2 mmol/kg was 63.9-86.1%, 75.8-91.4% and 80.6-90.6%, the specificity was 66.7-73.9%, 59.3-75.0%, and 59.3-75.0% and accuracy was 67.8-78.9%, 75.4-77.4%, and 76.3-81.0%, for the three dose groups, respectively. There were eight non-severe adverse events (AEs). Three serious AEs occurring in one patient were judged not related to gadodiamide by the on-site investigator. Conclusion: A significant dose trend between the four doses examined was observed. The lowest dose (0.01 mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1 mmol/kg gadodiamide appears to be the most suitable dose in diagnosing hemodynamically relevant RAS. The present study also demonstrated gadodiamide to be safe and well tolerated.

Original languageEnglish
Pages (from-to)456-464
Number of pages9
JournalEuropean Journal of Radiology
Volume64
Issue number3
DOIs
Publication statusPublished - Dec 2007

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gadodiamide
Renal Artery Obstruction
Magnetic Resonance Angiography
Digital Subtraction Angiography
Kidney
Safety
Renal Artery
Multicenter Studies
Body Weight
Research Personnel
Injections

Keywords

  • Angiography
  • Clinical trials
  • Digital subtraction angiography
  • Gd-DTPA-BMA
  • Intra-arterial
  • Magnetic resonance imaging
  • Phase II
  • Renal artery stenosis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA) : A phase II study. / Kittner, Thomas; Rudolf, Jens; Fages, Joan Falco; Legmann, Paul; Aschauer, Manuela; Repa, I.; Alvares, Marta Rodriguez; Savalegui, Ibone; Ittrich, Harald; Geterud, Kjell; de Kevviler, Eric; Ayuso, Juan; Lockhart, Mark E.; Blum, Alain; Iliasch, Herbert; Leisinger, Gerda; van Beek, E. J R; Reid, Allan W.; Brown, Jeffrey J.; Yu, Thomas C.; Flamm, Scott D.; Düber, Christoph; Judmaier, Werner; Reimer, Peter; Stiskal, Michael; Kramann, Bernhard; Wolff, Steve; Blankenstein, Christiane.

In: European Journal of Radiology, Vol. 64, No. 3, 12.2007, p. 456-464.

Research output: Contribution to journalArticle

Kittner, T, Rudolf, J, Fages, JF, Legmann, P, Aschauer, M, Repa, I, Alvares, MR, Savalegui, I, Ittrich, H, Geterud, K, de Kevviler, E, Ayuso, J, Lockhart, ME, Blum, A, Iliasch, H, Leisinger, G, van Beek, EJR, Reid, AW, Brown, JJ, Yu, TC, Flamm, SD, Düber, C, Judmaier, W, Reimer, P, Stiskal, M, Kramann, B, Wolff, S & Blankenstein, C 2007, 'Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): A phase II study', European Journal of Radiology, vol. 64, no. 3, pp. 456-464. https://doi.org/10.1016/j.ejrad.2007.02.034
Kittner, Thomas ; Rudolf, Jens ; Fages, Joan Falco ; Legmann, Paul ; Aschauer, Manuela ; Repa, I. ; Alvares, Marta Rodriguez ; Savalegui, Ibone ; Ittrich, Harald ; Geterud, Kjell ; de Kevviler, Eric ; Ayuso, Juan ; Lockhart, Mark E. ; Blum, Alain ; Iliasch, Herbert ; Leisinger, Gerda ; van Beek, E. J R ; Reid, Allan W. ; Brown, Jeffrey J. ; Yu, Thomas C. ; Flamm, Scott D. ; Düber, Christoph ; Judmaier, Werner ; Reimer, Peter ; Stiskal, Michael ; Kramann, Bernhard ; Wolff, Steve ; Blankenstein, Christiane. / Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA) : A phase II study. In: European Journal of Radiology. 2007 ; Vol. 64, No. 3. pp. 456-464.
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abstract = "Purpose: To determine the most efficacious dose of gadodiamide for three-dimensional (3D) contrast-enhanced (CE) magnetic resonance angiography (MRA) of the renal arteries on a patient level based on the sensitivity in detecting the main hemodynamically relevant (≥50{\%} or occlusion) renal artery stenosis (RAS) using intra-arterial digital subtraction angiography (IA DSA) as the gold standard. Materials and Methods: This prospective, randomized, double-blind, parallel-group, multicenter study included 273 patients referred to IA DSA for suspected RAS. Patients underwent 3D CE MRA after injection of 0.01, 0.05, 0.1, or 0.2 mmol/kg of body weight gadodiamide (0.5 mmol/ml). The images were assessed for location and degree of RAS by independent blinded readers (MRA: three readers, IA DSA: one reader). Hypothesis testing for a significant trend in sensitivity across dose groups was based on the one-sided Cochran-Armitage style trend test for each independent MRA reader. Results: The lowest dose group (0.01 mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., ≥50{\%} or occlusion) RAS. A statistically significant dose trend (p <0.001) was shown for each of the three independent readers. Depending on reader, the sensitivity obtained with 0.05, 0.1, and 0.2 mmol/kg was 63.9-86.1{\%}, 75.8-91.4{\%} and 80.6-90.6{\%}, the specificity was 66.7-73.9{\%}, 59.3-75.0{\%}, and 59.3-75.0{\%} and accuracy was 67.8-78.9{\%}, 75.4-77.4{\%}, and 76.3-81.0{\%}, for the three dose groups, respectively. There were eight non-severe adverse events (AEs). Three serious AEs occurring in one patient were judged not related to gadodiamide by the on-site investigator. Conclusion: A significant dose trend between the four doses examined was observed. The lowest dose (0.01 mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1 mmol/kg gadodiamide appears to be the most suitable dose in diagnosing hemodynamically relevant RAS. The present study also demonstrated gadodiamide to be safe and well tolerated.",
keywords = "Angiography, Clinical trials, Digital subtraction angiography, Gd-DTPA-BMA, Intra-arterial, Magnetic resonance imaging, Phase II, Renal artery stenosis",
author = "Thomas Kittner and Jens Rudolf and Fages, {Joan Falco} and Paul Legmann and Manuela Aschauer and I. Repa and Alvares, {Marta Rodriguez} and Ibone Savalegui and Harald Ittrich and Kjell Geterud and {de Kevviler}, Eric and Juan Ayuso and Lockhart, {Mark E.} and Alain Blum and Herbert Iliasch and Gerda Leisinger and {van Beek}, {E. J R} and Reid, {Allan W.} and Brown, {Jeffrey J.} and Yu, {Thomas C.} and Flamm, {Scott D.} and Christoph D{\"u}ber and Werner Judmaier and Peter Reimer and Michael Stiskal and Bernhard Kramann and Steve Wolff and Christiane Blankenstein",
year = "2007",
month = "12",
doi = "10.1016/j.ejrad.2007.02.034",
language = "English",
volume = "64",
pages = "456--464",
journal = "European Journal of Radiology",
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TY - JOUR

T1 - Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA)

T2 - A phase II study

AU - Kittner, Thomas

AU - Rudolf, Jens

AU - Fages, Joan Falco

AU - Legmann, Paul

AU - Aschauer, Manuela

AU - Repa, I.

AU - Alvares, Marta Rodriguez

AU - Savalegui, Ibone

AU - Ittrich, Harald

AU - Geterud, Kjell

AU - de Kevviler, Eric

AU - Ayuso, Juan

AU - Lockhart, Mark E.

AU - Blum, Alain

AU - Iliasch, Herbert

AU - Leisinger, Gerda

AU - van Beek, E. J R

AU - Reid, Allan W.

AU - Brown, Jeffrey J.

AU - Yu, Thomas C.

AU - Flamm, Scott D.

AU - Düber, Christoph

AU - Judmaier, Werner

AU - Reimer, Peter

AU - Stiskal, Michael

AU - Kramann, Bernhard

AU - Wolff, Steve

AU - Blankenstein, Christiane

PY - 2007/12

Y1 - 2007/12

N2 - Purpose: To determine the most efficacious dose of gadodiamide for three-dimensional (3D) contrast-enhanced (CE) magnetic resonance angiography (MRA) of the renal arteries on a patient level based on the sensitivity in detecting the main hemodynamically relevant (≥50% or occlusion) renal artery stenosis (RAS) using intra-arterial digital subtraction angiography (IA DSA) as the gold standard. Materials and Methods: This prospective, randomized, double-blind, parallel-group, multicenter study included 273 patients referred to IA DSA for suspected RAS. Patients underwent 3D CE MRA after injection of 0.01, 0.05, 0.1, or 0.2 mmol/kg of body weight gadodiamide (0.5 mmol/ml). The images were assessed for location and degree of RAS by independent blinded readers (MRA: three readers, IA DSA: one reader). Hypothesis testing for a significant trend in sensitivity across dose groups was based on the one-sided Cochran-Armitage style trend test for each independent MRA reader. Results: The lowest dose group (0.01 mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., ≥50% or occlusion) RAS. A statistically significant dose trend (p <0.001) was shown for each of the three independent readers. Depending on reader, the sensitivity obtained with 0.05, 0.1, and 0.2 mmol/kg was 63.9-86.1%, 75.8-91.4% and 80.6-90.6%, the specificity was 66.7-73.9%, 59.3-75.0%, and 59.3-75.0% and accuracy was 67.8-78.9%, 75.4-77.4%, and 76.3-81.0%, for the three dose groups, respectively. There were eight non-severe adverse events (AEs). Three serious AEs occurring in one patient were judged not related to gadodiamide by the on-site investigator. Conclusion: A significant dose trend between the four doses examined was observed. The lowest dose (0.01 mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1 mmol/kg gadodiamide appears to be the most suitable dose in diagnosing hemodynamically relevant RAS. The present study also demonstrated gadodiamide to be safe and well tolerated.

AB - Purpose: To determine the most efficacious dose of gadodiamide for three-dimensional (3D) contrast-enhanced (CE) magnetic resonance angiography (MRA) of the renal arteries on a patient level based on the sensitivity in detecting the main hemodynamically relevant (≥50% or occlusion) renal artery stenosis (RAS) using intra-arterial digital subtraction angiography (IA DSA) as the gold standard. Materials and Methods: This prospective, randomized, double-blind, parallel-group, multicenter study included 273 patients referred to IA DSA for suspected RAS. Patients underwent 3D CE MRA after injection of 0.01, 0.05, 0.1, or 0.2 mmol/kg of body weight gadodiamide (0.5 mmol/ml). The images were assessed for location and degree of RAS by independent blinded readers (MRA: three readers, IA DSA: one reader). Hypothesis testing for a significant trend in sensitivity across dose groups was based on the one-sided Cochran-Armitage style trend test for each independent MRA reader. Results: The lowest dose group (0.01 mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., ≥50% or occlusion) RAS. A statistically significant dose trend (p <0.001) was shown for each of the three independent readers. Depending on reader, the sensitivity obtained with 0.05, 0.1, and 0.2 mmol/kg was 63.9-86.1%, 75.8-91.4% and 80.6-90.6%, the specificity was 66.7-73.9%, 59.3-75.0%, and 59.3-75.0% and accuracy was 67.8-78.9%, 75.4-77.4%, and 76.3-81.0%, for the three dose groups, respectively. There were eight non-severe adverse events (AEs). Three serious AEs occurring in one patient were judged not related to gadodiamide by the on-site investigator. Conclusion: A significant dose trend between the four doses examined was observed. The lowest dose (0.01 mmol/kg) differed significantly from those of the other three doses. Based on the analysis of the primary and secondary endpoints, 0.1 mmol/kg gadodiamide appears to be the most suitable dose in diagnosing hemodynamically relevant RAS. The present study also demonstrated gadodiamide to be safe and well tolerated.

KW - Angiography

KW - Clinical trials

KW - Digital subtraction angiography

KW - Gd-DTPA-BMA

KW - Intra-arterial

KW - Magnetic resonance imaging

KW - Phase II

KW - Renal artery stenosis

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JO - European Journal of Radiology

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