Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): a phase II study.
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Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): a phase II study. a phase II study. / Kittner, Thomas; Rudolf, Jens; Fages, Joan Falco; Legmann, Paul; Aschauer, Manuela; Repa, Imre; 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: EUR J RADIOL, Jahrgang 64, Nr. 3, 3, 01.12.2007, S. 456-464.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance angiography (MRA): a phase II study.
T2 - a phase II study
AU - Kittner, Thomas
AU - Rudolf, Jens
AU - Fages, Joan Falco
AU - Legmann, Paul
AU - Aschauer, Manuela
AU - Repa, Imre
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 - 2007/12/1
Y1 - 2007/12/1
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 (> or =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 0.2mmol/kg of body weight gadodiamide (0.5mmol/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 (0.01mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., > or =50% or occlusion) RAS. A statistically significant dose trend (p
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 (> or =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 0.2mmol/kg of body weight gadodiamide (0.5mmol/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 (0.01mmol/kg) proved non-efficacious in detecting hemodynamically relevant (i.e., > or =50% or occlusion) RAS. A statistically significant dose trend (p
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Angiography, Digital Subtraction
KW - Contrast Media
KW - Dose-Response Relationship, Drug
KW - Double-Blind Method
KW - Female
KW - Gadolinium DTPA
KW - Humans
KW - Image Enhancement
KW - Image Processing, Computer-Assisted
KW - Imaging, Three-Dimensional
KW - Injections, Intravenous
KW - Magnetic Resonance Angiography
KW - Male
KW - Middle Aged
KW - Prospective Studies
KW - Renal Artery Obstruction
KW - Safety
KW - Sensitivity and Specificity
KW - Treatment Outcome
U2 - 10.1016/j.ejrad.2007.02.034
DO - 10.1016/j.ejrad.2007.02.034
M3 - SCORING: Journal article
C2 - 17412546
VL - 64
SP - 456
EP - 464
JO - EUR J RADIOL
JF - EUR J RADIOL
SN - 0720-048X
IS - 3
M1 - 3
ER -