PMID- 17412546
OWN - NLM
STAT- MEDLINE
DCOM- 20080225
LR  - 20151119
IS  - 0720-048X (Print)
IS  - 0720-048X (Linking)
VI  - 64
IP  - 3
DP  - 2007 Dec
TI  - Efficacy and safety of gadodiamide (Gd-DTPA-BMA) in renal 3D-magnetic resonance 
      angiography (MRA): a phase II study.
PG  - 456-64
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<0.001) was 
      shown for each of the three independent readers. Depending on reader, the 
      sensitivity obtained with 0.05, 0.1, and 0.2mmol/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 (0.01mmol/kg) differed significantly from 
      those of the other three doses. Based on the analysis of the primary and 
      secondary endpoints, 0.1mmol/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.
FAU - Kittner, Thomas
AU  - Kittner T
AD  - Hospital Dresden-Friedrichstadt, Germany. kittner-th@khdf.de
FAU - Rudolf, Jens
AU  - Rudolf J
FAU - Fages, Joan Falco
AU  - Fages JF
FAU - Legmann, Paul
AU  - Legmann P
FAU - Aschauer, Manuela
AU  - Aschauer M
FAU - Repa, Imre
AU  - Repa I
FAU - Alvares, Marta Rodriguez
AU  - Alvares MR
FAU - Savalegui, Ibone
AU  - Savalegui I
FAU - Ittrich, Harald
AU  - Ittrich H
FAU - Geterud, Kjell
AU  - Geterud K
FAU - de Kevviler, Eric
AU  - de Kevviler E
FAU - Ayuso, Juan
AU  - Ayuso J
FAU - Lockhart, Mark E
AU  - Lockhart ME
FAU - Blum, Alain
AU  - Blum A
FAU - Iliasch, Herbert
AU  - Iliasch H
FAU - Leisinger, Gerda
AU  - Leisinger G
FAU - van Beek, E J R
AU  - van Beek EJ
FAU - Reid, Allan W
AU  - Reid AW
FAU - Brown, Jeffrey J
AU  - Brown JJ
FAU - Yu, Thomas C
AU  - Yu TC
FAU - Flamm, Scott D
AU  - Flamm SD
FAU - Duber, Christoph
AU  - Duber C
FAU - Judmaier, Werner
AU  - Judmaier W
FAU - Reimer, Peter
AU  - Reimer P
FAU - Stiskal, Michael
AU  - Stiskal M
FAU - Kramann, Bernhard
AU  - Kramann B
FAU - Wolff, Steve
AU  - Wolff S
FAU - Blankenstein, Christiane
AU  - Blankenstein C
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20070406
PL  - Ireland
TA  - Eur J Radiol
JT  - European journal of radiology
JID - 8106411
RN  - 0 (Contrast Media)
RN  - 84F6U3J2R6 (gadodiamide)
RN  - K2I13DR72L (Gadolinium DTPA)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiography, Digital Subtraction
MH  - *Contrast Media/administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - *Gadolinium DTPA/administration & dosage/adverse effects
MH  - Humans
MH  - Image Enhancement/*methods
MH  - Image Processing, Computer-Assisted/methods
MH  - Imaging, Three-Dimensional/*methods
MH  - Injections, Intravenous
MH  - Magnetic Resonance Angiography/*methods
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Renal Artery Obstruction/*diagnosis
MH  - Safety
MH  - Sensitivity and Specificity
MH  - Treatment Outcome
EDAT- 2007/04/07 09:00
MHDA- 2008/02/26 09:00
CRDT- 2007/04/07 09:00
PHST- 2006/11/08 00:00 [received]
PHST- 2007/02/21 00:00 [revised]
PHST- 2007/02/23 00:00 [accepted]
PHST- 2007/04/07 09:00 [pubmed]
PHST- 2008/02/26 09:00 [medline]
PHST- 2007/04/07 09:00 [entrez]
AID - S0720-048X(07)00111-8 [pii]
AID - 10.1016/j.ejrad.2007.02.034 [doi]
PST - ppublish
SO  - Eur J Radiol. 2007 Dec;64(3):456-64. doi: 10.1016/j.ejrad.2007.02.034. Epub 2007 
      Apr 6.