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Clinical late phase II trials of MultiHance (Gd-BOPTA) for the magnetic resonance imaging of liver tumors in Japan.

Abstract：

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). CONCLUSION: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.

journal_name

J Comput Assist Tomogr

journal_title

Journal of computer assisted tomography

authors

Kuwatsuru R,Kadoya M,Ohtomo K,Tanimoto A,Hirohashi S,Murakami T,Tanaka Y,Yoshikawa K,Katayama H

doi

10.1097/00004728-199911001-00010

keywords:

subject

Has Abstract

pub_date

1999-11-01 00:00:00

pages

S65-74

eissn

0363-8715

issn

1532-3145

journal_volume

23 Suppl 1

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Clinical late phase II trials of MultiHance (Gd-BOPTA) for the magnetic resonance imaging of liver tumors in Japan.