| Evaluation of gadobenate dimeglumine in hepatocellular carcinoma: results from phase II and phase III clinical trials in Japan. | |
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MedLine Citation:
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PMID: 10508308 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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To evaluate the clinical efficacy of gadobenate dimeglumine (Gd-BOPTA)-enhanced magnetic resonance imaging for hepatocellular carcinoma (HCC), we reviewed the results of clinical phase II and III trials in Japan. Gd-BOPTA was administered at a dose of 0.1 mmol/kg to 139 patients who were suspected to have HCC. Dynamic phase images [breath-hold T1-weighted gradient echo (GRE)], spin-echo (SE) images obtained within 10 minutes of injection, and delayed breath-hold GRE images obtained 40-120 minutes after injection were evaluated. All post-contrast images were compared with T1- and T2-weighted pre-contrast images. The contrast efficacy for the dynamic study was classified as ( ) or (++) in 92.1% (128/139), in 43.1% (59/137) with SE within 10 minutes of injection, and in 43.2% (60/139) with breath-hold GRE at delayed phase. The increase in lesion-liver contrast-to-noise ratio was best at the arterial phase of dynamic breath-hold GRE. Liver signal-to-noise ratio showed a mean 52.3% increase in delayed phase. Additional information at delayed phase compared with images acquired within 10 minutes of injection (including the dynamic study) was classified as ( ) or (++) in 28.1% (39/139). With regard to safety, the overall incidence of adverse reactions was 5.0% (7/141) of the patients who were suspected to have HCC, all of whom recovered within 12 hours without any sequelae. No clinically important changes were observed in the blood and urine laboratory tests. It was concluded that Gd-BOPTA was well tolerated and effective in both dynamic study and delayed static imaging for the diagnosis of HCC. |
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Authors:
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A Tanimoto; R Kuwatsuru; M Kadoya; K Ohtomo; S Hirohashi; T Murakami; K Hiramatsu; K Yoshikawa; H Katayama |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of magnetic resonance imaging : JMRI Volume: 10 ISSN: 1053-1807 ISO Abbreviation: J Magn Reson Imaging Publication Date: 1999 Sep |
Date Detail:
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Created Date: 1999-11-18 Completed Date: 1999-11-18 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9105850 Medline TA: J Magn Reson Imaging Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 450-60 Citation Subset: IM |
Affiliation:
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Department of Diagnostic Radiology, Keio University School of Medicine, Tokyo 160-8582, Japan. tanimoto@t3.rim.or.jp |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Carcinoma, Hepatocellular / diagnosis* Clinical Trials, Phase II as Topic Clinical Trials, Phase III as Topic Contrast Media* / administration & dosage Female Humans Image Processing, Computer-Assisted Injections, Intravenous Japan Liver Neoplasms / diagnosis* Magnetic Resonance Imaging / methods* Male Meglumine / administration & dosage, analogs & derivatives*, diagnostic use Middle Aged Multicenter Studies as Topic Organometallic Compounds / administration & dosage, diagnostic use* |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media; 0/Organometallic Compounds; 113662-23-0/gadobenic acid; 6284-40-8/Meglumine |
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