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

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

Research output: Contribution to journalArticle

9 Citations (Scopus)

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 breath-hold) 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.

Original languageEnglish
JournalJournal of Computer Assisted Tomography
Volume23
Issue numberSUPPL.
Publication statusPublished - 1999 Nov
Externally publishedYes

Fingerprint

Phase II Clinical Trials
Japan
Magnetic Resonance Imaging
Liver
Neoplasms
Injections
Safety
Incidence
gadobenic acid
Contrast Media

Keywords

  • Contrast media
  • Gadolinium
  • Gd-BOPTA
  • Liver
  • Magnetic resonance imaging

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Clinical late phase II trials of MultiHance® (Gd-BOPTA) for the magnetic resonance imaging of liver tumors in Japan. / Kuwatsuru, Ryohei; Kadoya, Masumi; Ohtomo, Kuni; Tanimoto, Akihiro; Hirohashi, Shinji; Murakami, Takamichi; Tanaka, Yutaka; Yoshikawa, Kohki; Katayama, Hitoshi.

In: Journal of Computer Assisted Tomography, Vol. 23, No. SUPPL., 11.1999.

Research output: Contribution to journalArticle

Kuwatsuru, R, Kadoya, M, Ohtomo, K, Tanimoto, A, Hirohashi, S, Murakami, T, Tanaka, Y, Yoshikawa, K & Katayama, H 1999, 'Clinical late phase II trials of MultiHance® (Gd-BOPTA) for the magnetic resonance imaging of liver tumors in Japan', Journal of Computer Assisted Tomography, vol. 23, no. SUPPL..
Kuwatsuru, Ryohei ; Kadoya, Masumi ; Ohtomo, Kuni ; Tanimoto, Akihiro ; Hirohashi, Shinji ; Murakami, Takamichi ; Tanaka, Yutaka ; Yoshikawa, Kohki ; Katayama, Hitoshi. / Clinical late phase II trials of MultiHance® (Gd-BOPTA) for the magnetic resonance imaging of liver tumors in Japan. In: Journal of Computer Assisted Tomography. 1999 ; Vol. 23, No. SUPPL.
@article{f9ca8954e8b34512920e0c79c793ba13,
title = "Clinical late phase II trials of MultiHance{\circledR} (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 breath-hold) 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.",
keywords = "Contrast media, Gadolinium, Gd-BOPTA, Liver, Magnetic resonance imaging",
author = "Ryohei Kuwatsuru and Masumi Kadoya and Kuni Ohtomo and Akihiro Tanimoto and Shinji Hirohashi and Takamichi Murakami and Yutaka Tanaka and Kohki Yoshikawa and Hitoshi Katayama",
year = "1999",
month = "11",
language = "English",
volume = "23",
journal = "Journal of Computer Assisted Tomography",
issn = "0363-8715",
publisher = "Lippincott Williams and Wilkins",
number = "SUPPL.",

}

TY - JOUR

T1 - Clinical late phase II trials of MultiHance® (Gd-BOPTA) for the magnetic resonance imaging of liver tumors in Japan

AU - Kuwatsuru, Ryohei

AU - Kadoya, Masumi

AU - Ohtomo, Kuni

AU - Tanimoto, Akihiro

AU - Hirohashi, Shinji

AU - Murakami, Takamichi

AU - Tanaka, Yutaka

AU - Yoshikawa, Kohki

AU - Katayama, Hitoshi

PY - 1999/11

Y1 - 1999/11

N2 - 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 breath-hold) 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.

AB - 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 breath-hold) 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.

KW - Contrast media

KW - Gadolinium

KW - Gd-BOPTA

KW - Liver

KW - Magnetic resonance imaging

UR - http://www.scopus.com/inward/record.url?scp=0033394616&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033394616&partnerID=8YFLogxK

M3 - Article

C2 - 10608400

AN - SCOPUS:0033394616

VL - 23

JO - Journal of Computer Assisted Tomography

JF - Journal of Computer Assisted Tomography

SN - 0363-8715

IS - SUPPL.

ER -