• Je něco špatně v tomto záznamu ?

The Benefits of High Relaxivity for Brain Tumor Imaging: Results of a Multicenter Intraindividual Crossover Comparison of Gadobenate Dimeglumine with Gadoterate Meglumine (The BENEFIT Study)

M. Vaneckova, M. Herman, MP. Smith, M. Mechl, KR. Maravilla, J. Weichet, MV. Spampinato, J. Žižka, FJ. Wippold, JJ. Baima, R. Babbel, E. Bültmann, RY. Huang, JH. Buhk, A. Bonafé, C. Colosimo, S. Lui, MA. Kirchin, N. Shen, G. Pirovano, A. Spinazzi,

. 2015 ; 36 (9) : 1589-98. [pub] 20150716

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc16020526

BACKGROUND AND PURPOSE: Gadobenate dimeglumine (MultiHance) has higher r1 relaxivity than gadoterate meglumine (Dotarem) which may permit the use of lower doses for MR imaging applications. Our aim was to compare 0.1- and 0.05-mmol/kg body weight gadobenate with 0.1-mmol/kg body weight gadoterate for MR imaging assessment of brain tumors. MATERIALS AND METHODS: We performed crossover, intraindividual comparison of 0.1-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 1) and 0.05-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 2). Adult patients with suspected or known brain tumors were randomized to Arm 1 (70 patients) or Arm 2 (107 patients) and underwent 2 identical examinations at 1.5 T. The agents were injected in randomized-sequence order, and the 2 examinations were separated by 2-14 days. MR imaging scanners, imaging sequences (T1-weighted spin-echo and T1-weighted high-resolution gradient-echo), and acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images for diagnostic information (degree of definition of lesion extent, lesion border delineation, visualization of lesion internal morphology, contrast enhancement) and quantitatively for percentage lesion enhancement and lesion-to-background ratio. Safety assessments were performed. RESULTS: In Arm 1, a highly significant superiority (P < .002) of 0.1-mmol/kg gadobenate was demonstrated by all readers for all end points. In Arm 2, no significant differences (P > .1) were observed for any reader and any end point, with the exception of percentage enhancement for reader 2 (P < .05) in favor of 0.05-mmol/kg gadobenate. Study agent-related adverse events were reported by 2/169 (1.2%) patients after gadobenate and by 5/175 (2.9%) patients after gadoterate. CONCLUSIONS: Significantly superior morphologic information and contrast enhancement are demonstrated on brain MR imaging with 0.1-mmol/kg gadobenate compared with 0.1-mmol/kg gadoterate. No meaningful differences were recorded between 0.05-mmol/kg gadobenate and 0.1-mmol/kg gadoterate.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc16020526
003      
CZ-PrNML
005      
20161018094325.0
007      
ta
008      
160722s2015 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.3174/ajnr.A4468 $2 doi
024    7_
$a 10.3174/ajnr.A4468 $2 doi
035    __
$a (PubMed)26185325
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Vaneckova, M $u From the Charles University in Prague (M.V.), First Faculty of Medicine and General University Hospital, Prague, Czech Republic man.van@post.cz.
245    14
$a The Benefits of High Relaxivity for Brain Tumor Imaging: Results of a Multicenter Intraindividual Crossover Comparison of Gadobenate Dimeglumine with Gadoterate Meglumine (The BENEFIT Study) / $c M. Vaneckova, M. Herman, MP. Smith, M. Mechl, KR. Maravilla, J. Weichet, MV. Spampinato, J. Žižka, FJ. Wippold, JJ. Baima, R. Babbel, E. Bültmann, RY. Huang, JH. Buhk, A. Bonafé, C. Colosimo, S. Lui, MA. Kirchin, N. Shen, G. Pirovano, A. Spinazzi,
520    9_
$a BACKGROUND AND PURPOSE: Gadobenate dimeglumine (MultiHance) has higher r1 relaxivity than gadoterate meglumine (Dotarem) which may permit the use of lower doses for MR imaging applications. Our aim was to compare 0.1- and 0.05-mmol/kg body weight gadobenate with 0.1-mmol/kg body weight gadoterate for MR imaging assessment of brain tumors. MATERIALS AND METHODS: We performed crossover, intraindividual comparison of 0.1-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 1) and 0.05-mmol/kg gadobenate with 0.1-mmol/kg gadoterate (Arm 2). Adult patients with suspected or known brain tumors were randomized to Arm 1 (70 patients) or Arm 2 (107 patients) and underwent 2 identical examinations at 1.5 T. The agents were injected in randomized-sequence order, and the 2 examinations were separated by 2-14 days. MR imaging scanners, imaging sequences (T1-weighted spin-echo and T1-weighted high-resolution gradient-echo), and acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images for diagnostic information (degree of definition of lesion extent, lesion border delineation, visualization of lesion internal morphology, contrast enhancement) and quantitatively for percentage lesion enhancement and lesion-to-background ratio. Safety assessments were performed. RESULTS: In Arm 1, a highly significant superiority (P < .002) of 0.1-mmol/kg gadobenate was demonstrated by all readers for all end points. In Arm 2, no significant differences (P > .1) were observed for any reader and any end point, with the exception of percentage enhancement for reader 2 (P < .05) in favor of 0.05-mmol/kg gadobenate. Study agent-related adverse events were reported by 2/169 (1.2%) patients after gadobenate and by 5/175 (2.9%) patients after gadoterate. CONCLUSIONS: Significantly superior morphologic information and contrast enhancement are demonstrated on brain MR imaging with 0.1-mmol/kg gadobenate compared with 0.1-mmol/kg gadoterate. No meaningful differences were recorded between 0.05-mmol/kg gadobenate and 0.1-mmol/kg gadoterate.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a nádory mozku $x patologie $7 D001932
650    _2
$a kontrastní látky $7 D003287
650    _2
$a klinické křížové studie $7 D018592
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a magnetická rezonanční tomografie $x metody $7 D008279
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a meglumin $x analogy a deriváty $7 D008536
650    _2
$a lidé středního věku $7 D008875
650    _2
$a organokovové sloučeniny $7 D009942
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Herman, M $u University Hospital Olomouc (M.H.), Olomouc, Czech Republic.
700    1_
$a Smith, M P $u Beth Israel Deaconess Medical Center (M.P.S.), Boston, Massachusetts.
700    1_
$a Mechl, M $u Faculty of Medicine (M.M.), University Hospital Brno, Masaryk University, Brno, Czech Republic.
700    1_
$a Maravilla, K R $u MR Research Laboratory (K.R.M.), University of Washington, Seattle, Washington.
700    1_
$a Weichet, J $u Na Homolce Hospital (J.W.), Prague, Czech Republic.
700    1_
$a Spampinato, M V $u Department of Radiology and Radiological Science (M.V.S.), Medical University of South Carolina, Charleston, South Carolina.
700    1_
$a Žižka, J $u University Faculty of Medicine in Hradec Králové (J.Ž.), University Hospital Hradec Králové and Charles University in Prague, Prague, Czech Republic.
700    1_
$a Wippold, F J $u Mallinckrodt Institute of Radiology (F.J.W.), Washington University School of Medicine, St. Louis, Missouri.
700    1_
$a Baima, J J $u Clinical Radiologists, S.C. (J.J.B.), Springfield, Illinois.
700    1_
$a Babbel, R $u Good Samaritan Regional Medical Center (R.B.), Corvallis, Oregon.
700    1_
$a Bültmann, E $u Institute of Diagnostic and Interventional Neuroradiology (E.B.), Hannover, Germany.
700    1_
$a Huang, R Y $u Harvard Medical School (R.Y.H.), Brigham and Women's Hospital, Boston, Massachusetts.
700    1_
$a Buhk, J-H $u University Medical Center Hamburg Eppendorf (J.-H.B.), Hamburg, Germany.
700    1_
$a Bonafé, A $u Hopital Gui de Chauliac (A.B.), Montpellier, France.
700    1_
$a Colosimo, C $u Policlinico "Agostino Gemelli" (C.C.), Rome, Italy.
700    1_
$a Lui, S $u West China Hospital of Sichuan University (S.L.), Chengdu, Sichuan, China.
700    1_
$a Kirchin, M A $u Global Medical & Regulatory Affairs (M.A.K.), Bracco Imaging S.p.A., Milan, Italy.
700    1_
$a Shen, N $u Global Medical & Regulatory Affairs (N.S., G.P., A.S.), Bracco Diagnostics, Monroe, New Jersey.
700    1_
$a Pirovano, G $u Global Medical & Regulatory Affairs (N.S., G.P., A.S.), Bracco Diagnostics, Monroe, New Jersey.
700    1_
$a Spinazzi, A $u Global Medical & Regulatory Affairs (N.S., G.P., A.S.), Bracco Diagnostics, Monroe, New Jersey.
773    0_
$w MED00009116 $t AJNR. American journal of neuroradiology $x 1936-959X $g Roč. 36, č. 9 (2015), s. 1589-98
856    41
$u https://pubmed.ncbi.nlm.nih.gov/26185325 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20160722 $b ABA008
991    __
$a 20161018094729 $b ABA008
999    __
$a ok $b bmc $g 1155196 $s 945054
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2015 $b 36 $c 9 $d 1589-98 $e 20150716 $i 1936-959X $m American journal of neuroradiology $n AJNR Am J Neuroradiol $x MED00009116
LZP    __
$a Pubmed-20160722

Najít záznam

Citační ukazatele

Pouze přihlášení uživatelé

Možnosti archivace

Nahrávání dat ...