Focal liver lesions: Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study

Jan Petersein, Alberto Spinazzi, Andrea Giovagnoni, Philippe Soyer, Francois Terrier, Riccardo Lencioni, Carlo Bartolozzi, Luigi Grazioli, Antonio Chiesa, Riccardo Manfredi, Pasquale Marano, Els L. Van Persijn Van Meerten, Johannes L. Bloem, Carina Petre, Guy Marchal, Alina Greco, Michael T. McNamara, Andreas Heuck, Maximilian Reiser, Michael LaniadoClaus Claussen, Heike E. Daldrup, Ernst Rummeny, Miles A. Kirchin, Gianpaolo Pirovano, Bernd Hamm

Research output: Contribution to journalArticle

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Abstract

PURPOSE: To evaluate gadobenate dimeglumine (Gd-BOPTA) for dynamic and delayed magnetic resonance (MR)imaging of focal liver lesions. MATERIALS AND METHODS: In 126 of 214 patients, MR imaging was performed before Gd-BOPTA administration, immediately after bolus administration of a 0.05-mmol/kg dose of Gd-BOPTA, and 60-120 minutes after an additional intravenously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed before and 60-120 minutes after a single, intravenously infused 0.1-mmol/kg dose. T1- and T2- weighted spin-echo and T1-weighted gradient-echo images were acquired. On- site and blinded off-site reviewers prospectively evaluated all images. Intraoperatire ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference methods in 110 patients. RESULTS: Significantly more lesions were detected on combined pre- and postcontrast images compared with on precontrast images alone (P <.01). All reviewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-site reviewers and two off-site reviewers reported increased overall diagnostic confidence (P <.01). Additional lesion characterization information was provided on up to 109 (59%) of 184 delayed images and for up to 50 (42%) of 118 patients in whom dynamic images were assessed. Gd-BOPTA would have helped change the diagnosis in 99 (47%) of 209 cases and affected patient treatment in 408 (23%) of 209 cases. CONCLUSION: Gd-BOPTA increases liver lesion conspicuity and detectability and aids in the characterization of lesions.

Original languageEnglish (US)
Pages (from-to)727-736
Number of pages10
JournalRadiology
Volume215
Issue number3
StatePublished - Jun 2000
Externally publishedYes

Fingerprint

Magnetic Resonance Imaging
Liver
Tomography
Portography
Ethiodized Oil
Clinical Studies
gadobenic acid
Ultrasonography
Therapeutics

Keywords

  • Contrast media
  • Gadobenate dimeglumine
  • Liver neoplasms
  • Liver neoplasms, MR
  • Magnetic resonance (MR), contrast media
  • Magnetic resonance (MR), phase imaging

ASJC Scopus subject areas

  • Radiological and Ultrasound Technology

Cite this

Petersein, J., Spinazzi, A., Giovagnoni, A., Soyer, P., Terrier, F., Lencioni, R., ... Hamm, B. (2000). Focal liver lesions: Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study. Radiology, 215(3), 727-736.

Focal liver lesions : Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study. / Petersein, Jan; Spinazzi, Alberto; Giovagnoni, Andrea; Soyer, Philippe; Terrier, Francois; Lencioni, Riccardo; Bartolozzi, Carlo; Grazioli, Luigi; Chiesa, Antonio; Manfredi, Riccardo; Marano, Pasquale; Van Persijn Van Meerten, Els L.; Bloem, Johannes L.; Petre, Carina; Marchal, Guy; Greco, Alina; McNamara, Michael T.; Heuck, Andreas; Reiser, Maximilian; Laniado, Michael; Claussen, Claus; Daldrup, Heike E.; Rummeny, Ernst; Kirchin, Miles A.; Pirovano, Gianpaolo; Hamm, Bernd.

In: Radiology, Vol. 215, No. 3, 06.2000, p. 727-736.

Research output: Contribution to journalArticle

Petersein, J, Spinazzi, A, Giovagnoni, A, Soyer, P, Terrier, F, Lencioni, R, Bartolozzi, C, Grazioli, L, Chiesa, A, Manfredi, R, Marano, P, Van Persijn Van Meerten, EL, Bloem, JL, Petre, C, Marchal, G, Greco, A, McNamara, MT, Heuck, A, Reiser, M, Laniado, M, Claussen, C, Daldrup, HE, Rummeny, E, Kirchin, MA, Pirovano, G & Hamm, B 2000, 'Focal liver lesions: Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study', Radiology, vol. 215, no. 3, pp. 727-736.
Petersein J, Spinazzi A, Giovagnoni A, Soyer P, Terrier F, Lencioni R et al. Focal liver lesions: Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study. Radiology. 2000 Jun;215(3):727-736.
Petersein, Jan ; Spinazzi, Alberto ; Giovagnoni, Andrea ; Soyer, Philippe ; Terrier, Francois ; Lencioni, Riccardo ; Bartolozzi, Carlo ; Grazioli, Luigi ; Chiesa, Antonio ; Manfredi, Riccardo ; Marano, Pasquale ; Van Persijn Van Meerten, Els L. ; Bloem, Johannes L. ; Petre, Carina ; Marchal, Guy ; Greco, Alina ; McNamara, Michael T. ; Heuck, Andreas ; Reiser, Maximilian ; Laniado, Michael ; Claussen, Claus ; Daldrup, Heike E. ; Rummeny, Ernst ; Kirchin, Miles A. ; Pirovano, Gianpaolo ; Hamm, Bernd. / Focal liver lesions : Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study. In: Radiology. 2000 ; Vol. 215, No. 3. pp. 727-736.
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abstract = "PURPOSE: To evaluate gadobenate dimeglumine (Gd-BOPTA) for dynamic and delayed magnetic resonance (MR)imaging of focal liver lesions. MATERIALS AND METHODS: In 126 of 214 patients, MR imaging was performed before Gd-BOPTA administration, immediately after bolus administration of a 0.05-mmol/kg dose of Gd-BOPTA, and 60-120 minutes after an additional intravenously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed before and 60-120 minutes after a single, intravenously infused 0.1-mmol/kg dose. T1- and T2- weighted spin-echo and T1-weighted gradient-echo images were acquired. On- site and blinded off-site reviewers prospectively evaluated all images. Intraoperatire ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference methods in 110 patients. RESULTS: Significantly more lesions were detected on combined pre- and postcontrast images compared with on precontrast images alone (P <.01). All reviewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-site reviewers and two off-site reviewers reported increased overall diagnostic confidence (P <.01). Additional lesion characterization information was provided on up to 109 (59{\%}) of 184 delayed images and for up to 50 (42{\%}) of 118 patients in whom dynamic images were assessed. Gd-BOPTA would have helped change the diagnosis in 99 (47{\%}) of 209 cases and affected patient treatment in 408 (23{\%}) of 209 cases. CONCLUSION: Gd-BOPTA increases liver lesion conspicuity and detectability and aids in the characterization of lesions.",
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T2 - Evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study

AU - Petersein, Jan

AU - Spinazzi, Alberto

AU - Giovagnoni, Andrea

AU - Soyer, Philippe

AU - Terrier, Francois

AU - Lencioni, Riccardo

AU - Bartolozzi, Carlo

AU - Grazioli, Luigi

AU - Chiesa, Antonio

AU - Manfredi, Riccardo

AU - Marano, Pasquale

AU - Van Persijn Van Meerten, Els L.

AU - Bloem, Johannes L.

AU - Petre, Carina

AU - Marchal, Guy

AU - Greco, Alina

AU - McNamara, Michael T.

AU - Heuck, Andreas

AU - Reiser, Maximilian

AU - Laniado, Michael

AU - Claussen, Claus

AU - Daldrup, Heike E.

AU - Rummeny, Ernst

AU - Kirchin, Miles A.

AU - Pirovano, Gianpaolo

AU - Hamm, Bernd

PY - 2000/6

Y1 - 2000/6

N2 - PURPOSE: To evaluate gadobenate dimeglumine (Gd-BOPTA) for dynamic and delayed magnetic resonance (MR)imaging of focal liver lesions. MATERIALS AND METHODS: In 126 of 214 patients, MR imaging was performed before Gd-BOPTA administration, immediately after bolus administration of a 0.05-mmol/kg dose of Gd-BOPTA, and 60-120 minutes after an additional intravenously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed before and 60-120 minutes after a single, intravenously infused 0.1-mmol/kg dose. T1- and T2- weighted spin-echo and T1-weighted gradient-echo images were acquired. On- site and blinded off-site reviewers prospectively evaluated all images. Intraoperatire ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference methods in 110 patients. RESULTS: Significantly more lesions were detected on combined pre- and postcontrast images compared with on precontrast images alone (P <.01). All reviewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-site reviewers and two off-site reviewers reported increased overall diagnostic confidence (P <.01). Additional lesion characterization information was provided on up to 109 (59%) of 184 delayed images and for up to 50 (42%) of 118 patients in whom dynamic images were assessed. Gd-BOPTA would have helped change the diagnosis in 99 (47%) of 209 cases and affected patient treatment in 408 (23%) of 209 cases. CONCLUSION: Gd-BOPTA increases liver lesion conspicuity and detectability and aids in the characterization of lesions.

AB - PURPOSE: To evaluate gadobenate dimeglumine (Gd-BOPTA) for dynamic and delayed magnetic resonance (MR)imaging of focal liver lesions. MATERIALS AND METHODS: In 126 of 214 patients, MR imaging was performed before Gd-BOPTA administration, immediately after bolus administration of a 0.05-mmol/kg dose of Gd-BOPTA, and 60-120 minutes after an additional intravenously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed before and 60-120 minutes after a single, intravenously infused 0.1-mmol/kg dose. T1- and T2- weighted spin-echo and T1-weighted gradient-echo images were acquired. On- site and blinded off-site reviewers prospectively evaluated all images. Intraoperatire ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference methods in 110 patients. RESULTS: Significantly more lesions were detected on combined pre- and postcontrast images compared with on precontrast images alone (P <.01). All reviewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-site reviewers and two off-site reviewers reported increased overall diagnostic confidence (P <.01). Additional lesion characterization information was provided on up to 109 (59%) of 184 delayed images and for up to 50 (42%) of 118 patients in whom dynamic images were assessed. Gd-BOPTA would have helped change the diagnosis in 99 (47%) of 209 cases and affected patient treatment in 408 (23%) of 209 cases. CONCLUSION: Gd-BOPTA increases liver lesion conspicuity and detectability and aids in the characterization of lesions.

KW - Contrast media

KW - Gadobenate dimeglumine

KW - Liver neoplasms

KW - Liver neoplasms, MR

KW - Magnetic resonance (MR), contrast media

KW - Magnetic resonance (MR), phase imaging

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