Focal liver lesions: evaluation of the efficacy of gadobenate dimeglumine in MR imaging--a multicenter phase III clinical study.
OBJECTIVE
To evaluate gadobenate dimeglumine (Gd-BOPTA) for dynamic and delayed magnetic resonance (MR) imaging of focal liver lesions.


METHODS
In 126 of 214 patients, MR imaging was performed before Gd-BOPTA administration, immediately after bolus administration of a 0.05- mmol/kg dose of Gd-BOPTA, and 60-120 minutes after an additional intravenously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed before and 60-120 minutes after a single, intravenously infused 0.1-mmol/kg dose. T1- and T2-weighted spin-echo and T1-weighted gradient-echo images were acquired. On-site and blinded off-site reviewers prospectively evaluated all images. Intraoperative ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference methods in 110 patients.


RESULTS
Significantly more lesions were detected on combined pre- and postcontrast images compared with on precontrast images alone (P <. 01). All reviewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-site reviewers and two off-site reviewers reported increased overall diagnostic confidence (P <.01). Additional lesion characterization information was provided on up to 109 (59%) of 184 delayed images and for up to 50 (42%) of 118 patients in whom dynamic images were assessed. Gd-BOPTA would have helped change the diagnosis in 99 (47%) of 209 cases and affected patient treatment in 408 (23%) of 209 cases.


CONCLUSIONS
Gd-BOPTA increases liver lesion conspicuity and detectability and aids in the characterization of lesions.
Petersein
J
J
Institute for Radiodiagnostics, Medizinische Fakultät, Humboldt-Universität, Berlin, Germany.
Spinazzi
A
A
Giovagnoni
A
A
Soyer
P
P
Terrier
F
F
Lencioni
R
R
Bartolozzi
C
C
Grazioli
L
L
Chiesa
A
A
Manfredi
R
R
Marano
P
P
Van Persijn Van Meerten
E L
EL
Bloem
J L
JL
Petre
C
C
Marchal
G
G
Greco
A
A
McNamara
M T
MT
Heuck
A
A
Reiser
M
M
Laniado
M
M
Claussen
C
C
Daldrup
H E
HE
Rummeny
E
E
Kirchin
M A
MA
Pirovano
G
G
Hamm
B
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage; D005060:Europe; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage; D006801:Humans; D008099:Liver / Q000473:pathology*; D008113:Liver Neoplasms / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage; D011446:Prospective Studies; D012680:Sensitivity and Specificity
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium