Clinical late phase II trials of MultiHance (Gd-BOPTA) for the magnetic resonance imaging of liver tumors in Japan.
OBJECTIVE
The purpose of the study was to evaluate the safety and efficacy of Gd-BOPTA for liver imaging and to determine the most appropriate clinical dose to administer.


METHODS
Gd-BOPTA was administered at a dose of 0.05 (group A), 0.1 (group B), or 0.2 (group C) mmol/kg to 201 patients suspected of having malignant liver tumors who had been referred for magnetic resonance imaging. Dynamic phase images (T1-weighted gradient echo sequences obtained during breath-hold), images obtained within 10 min of Gd-BOPTA injection (spin echo images) and delayed images obtained at 40-120 min after Gd-BOPTA injection (T1-weighted spin echo and gradient echo sequences during breathhold) were acquired. All post-contrast images were compared with pre-contrast images (T1- and T2-weighted sequences) obtained immediately prior to Gd-BOPTA administration. Safety was assessed in terms of the incidence of adverse events.


RESULTS
The contrast efficacy for the dynamic study was classified as ( ) in 39.7% (27/68), 55.4% (36/65), and 47.0% (31/66) for groups A, B, and C, respectively. The contrast efficacy within 10 min of the injection was classified as ( ) in 7.6% (5/66), 16.9% (11/65), and 12.5% (8/64) for groups A, B, and C, respectively. The contrast efficacy at 40-120 min post-injection was classified as ( ) in 4.4% (3/68), 21.5% (14/65), and 20.0% (13/65) for groups A, B, and C, respectively with significant differences noted between groups A and B and groups A and C. As regards safety, the overall incidence of adverse reactions was 3.5% (7/199).


CONCLUSIONS
Gd-BOPTA is a safe and efficacious contrast agent for use in both dynamic phase imaging and delayed (40-120 min) static imaging. A dose of 0.1 mmol/kg Gd-BOPTA appears to be the ideal dose for use in liver imaging in Japan.
Kuwatsuru
R
R
Department of Radiology, Juntendo University School of Medicine, Tokyo, Japan. kuwaturu@med.juntendo.ac.jp
Kadoya
M
M
Ohtomo
K
K
Tanimoto
A
A
Hirohashi
S
S
Murakami
T
T
Tanaka
Y
Y
Yoshikawa
K
K
Katayama
H
H
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000175:diagnosis / Q000378:metabolism; D001653:Bile Ducts, Intrahepatic / Q000473:pathology; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis* / Q000378:metabolism; D018281:Cholangiocarcinoma / Q000175:diagnosis / Q000378:metabolism; D003287:Contrast Media / Q000493:pharmacokinetics; D003937:Diagnosis, Differential; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage / Q000493:pharmacokinetics; D006801:Humans; D007564:Japan; D008099:Liver / Q000378:metabolism / Q000473:pathology*; D008113:Liver Neoplasms / Q000175:diagnosis* / Q000378:metabolism; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics; D012189:Retrospective Studies; D012449:Safety
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium