Evaluation of gadobenate dimeglumine in hepatocellular carcinoma

Results from phase II and phase III clinical trials in Japan

Akihiro Tanimoto, Ryohei Kuwatsuru, Masumi Kadoya, Kuni Ohtomo, Shinji Hirohashi, Takamichi Murakami, Kyoichi Hiramatsu, Kohki Yoshikawa, Hitoshi Katayama

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)450-460
Number of pages11
JournalJournal of Magnetic Resonance Imaging
Volume10
Issue number3
DOIs
Publication statusPublished - 1999 Sep

Fingerprint

Phase III Clinical Trials
Hepatocellular Carcinoma
Japan
Injections
Phase II Clinical Trials
Liver
Signal-To-Noise Ratio
Noise
Magnetic Resonance Imaging
Urine
Safety
gadobenic acid
Incidence

Keywords

  • Contrast media
  • Gadolinium
  • Gd-BOPTA
  • Gd-DTPA
  • Hepatocellular carcinoma
  • Liver
  • Magnetic resonance imaging

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Evaluation of gadobenate dimeglumine in hepatocellular carcinoma : Results from phase II and phase III clinical trials in Japan. / Tanimoto, Akihiro; Kuwatsuru, Ryohei; Kadoya, Masumi; Ohtomo, Kuni; Hirohashi, Shinji; Murakami, Takamichi; Hiramatsu, Kyoichi; Yoshikawa, Kohki; Katayama, Hitoshi.

In: Journal of Magnetic Resonance Imaging, Vol. 10, No. 3, 09.1999, p. 450-460.

Research output: Contribution to journalArticle

Tanimoto, Akihiro ; Kuwatsuru, Ryohei ; Kadoya, Masumi ; Ohtomo, Kuni ; Hirohashi, Shinji ; Murakami, Takamichi ; Hiramatsu, Kyoichi ; Yoshikawa, Kohki ; Katayama, Hitoshi. / Evaluation of gadobenate dimeglumine in hepatocellular carcinoma : Results from phase II and phase III clinical trials in Japan. In: Journal of Magnetic Resonance Imaging. 1999 ; Vol. 10, No. 3. pp. 450-460.
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abstract = "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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