Phase II clinical evaluation of Gd-EOB-DTPA: dose, safety aspects, and pulse sequence.

Reimer, Peter; Rummeny, EJ; Shamsi, Kohkan; Balzer, Thomas; Daldrup, H E; Tombach, Bernd; Hesse, Thomas; Berns, T.; Peters, P. E.

doi:10.1148/radiology.199.1.8633143

Cited by 284 publications

(193 citation statements)

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“…Previous studies have demonstrated that Gd-EOB-DTPA is well tolerated and has no substantial adverse events and minor adverse events of 5.9% (6,7,19). In fact, there were no severe adverse effects in our study population.…”

Section: Discussionsupporting

confidence: 49%

Dynamic contrast‐enhanced magnetic resonance imaging of abdominal solid organ and major vessel: Comparison of enhancement effect between Gd‐EOB‐DTPA and Gd‐DTPA

Tamada

Ito

Sone

et al. 2009

Magnetic Resonance Imaging

110

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Purpose:To evaluate the differences in enhancement of the abdominal solid organ and the major vessel on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) obtained with gadolinium ethoxybenzyldiethylenetriamine pentaacetic acid (Gd-EOB-DTPA: EOB) and gadolinium diethylenetriamine pentaacetic acid (Gd-DTPA) in the same patients. Materials and Methods:A total of 13 healthy volunteers underwent repeat assessments of abdominal MR examinations with DCE-MRI using either Gd-DTPA at a dose of 0.1 mmol/kg body weight or EOB at a dose of 0.025 mmol/kg body weight. DCE images were obtained at precontrast injection and in the arterial phase (AP: 25 seconds), portal phase (PP: 70 seconds), and equilibrium phase (EP: 3 minutes). The signal intensities (SIs) of liver at AP, PP, and EP; the SIs of spleen, renal cortex, renal medulla, pancreas, adrenal gland, aorta at AP; and the SIs of portal vein and inferior vena cava (IVC) at PP were defined using region-ofinterest measurements, and were used for calculation of signal intensity ratio (SIR). There was no significant difference in mean SIR of liver at PP between EOB (0.529 Ϯ 0.124) and Gd-DTPA (0.564 Ϯ 0.139). Conversely, the mean SIR of liver at EP was significantly higher with EOB (0.576 Ϯ 0.167) than with Gd-DTPA (0.396 Ϯ 0.093) (P Ͻ 0.001). Results Conclusion:Lower arterial vascular and parenchymal enhancement with Gd-EOB, as compared with Gd-DTPA, may require reassessment of its dose, despite the higher late venous phase liver parenchymal enhancement.

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Section: Discussionsupporting

confidence: 49%

Dynamic contrast‐enhanced magnetic resonance imaging of abdominal solid organ and major vessel: Comparison of enhancement effect between Gd‐EOB‐DTPA and Gd‐DTPA

Tamada

Ito

Sone

et al. 2009

Magnetic Resonance Imaging

110

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“…17 A recent intraindividual comparison of 0.025 and 0.05 mmol/kg in patients with cirrhosis suggested significant improvement of liver-to-lesion (hepatocellular carcinoma) contrast in patients with decreased hepatic function (Child-Pugh class B disease) but not in patients with preserved hepatic function (Child-Pugh class A disease). 21 A study performed in the early stages of gadoxetic acid development also showed that liver-to-lesion contrast during the hepatobiliary phase was not necessarily higher using 0.05 compared with 0.025 mmol/kg, although the degree of enhancement compared to precontrast images was consistently higher using 0.05 mmol/kg.…”

Section: Discussionmentioning

confidence: 99%

“…13,14 The approved package insert dose of gadoxetic acid, 0.025 mmol/kg, yields a quarter of the dose of gadolinium of traditional formulation agents, including gadopentetate dimeglumine, gadoteridol, gadodiamide, gadoversetamide, and gadobenate dimeglumine. 15 This dose was determined based on preclinical studies 16,17 that demonstrated comparable early enhancement of hypervascular tumors between MRI with a 0.025 mmol/kg dose showed comparable early enhancement of hypervascular tumors to gadopentetate dimeglumine 16 A dose of 0.025 mmol/kg was also found to be the minimum effective dose during the hepatobiliary phase for the detection and characterization of lesions. 17 However, the imaging sequences used in these studies (both published in 1996) are no longer routinely used in clinical MR imaging.…”

Section: Introductionmentioning

confidence: 99%

“…15 This dose was determined based on preclinical studies 16,17 that demonstrated comparable early enhancement of hypervascular tumors between MRI with a 0.025 mmol/kg dose showed comparable early enhancement of hypervascular tumors to gadopentetate dimeglumine 16 A dose of 0.025 mmol/kg was also found to be the minimum effective dose during the hepatobiliary phase for the detection and characterization of lesions. 17 However, the imaging sequences used in these studies (both published in 1996) are no longer routinely used in clinical MR imaging. In fact, many institutions have adopted the use of higher doses, such as a fixed dose of 10 mL rather than a dose based on patient weight, as a standard in clinical MR imaging.…”

Section: Introductionmentioning

confidence: 99%

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Intraindividual Crossover Comparison of Gadoxetic Acid Dose for Liver MRI in Normal Volunteers

Bannas

Hernando

Rahimi

et al. 2016

MRMS

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Purpose: We performed a quantitative intraindividual comparison of the performance of 0.025-and 0.05-mmol/kg doses for gadoxetic acid-enhanced liver magnetic resonance (MR) imaging.Materials and Methods: Eleven healthy volunteers underwent liver MR imaging twice, once with a 0.025-and once with a 0.05-mmol/kg dose of gadoxetic acid. MR spectroscopy and 3-dimensional gradient-echo T 1 -weighted images (3D-GRE) were obtained before and 3, 10, and 20 min after injection of the contrast medium to measure T 1 and T 2 values and signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) performance. During the dynamic phase, highly time-resolved 3D-GRE was used to estimate the relative CNR (CNR rel ) of the hepatic artery and portal vein (PV) to the liver. We used paired t-tests to compare the results of different doses.Results: During the hepatobiliary phase, we observed shorter T 1 values and higher SNRs of the liver (P < 0.001) and higher liver-to-PV and liver-to-muscle CNRs (P < 0.002) using 0.05 mmol/kg compared to 0.025 mmol/kg. Increasing the dose to 0.05 mmol/kg yielded a greater T 1 -shortening effect at 10 min delay even compared with 0.025 mmol/kg at 20 min (P < 0.001). During the dynamic phase, the peak CNR rel for the hepatic artery and portal vein were higher using 0.05 mmol/kg (P = 0.007 to 0.035).Conclusion: Use of gadoxetic acid at a dose of 0.05 mmol/kg leads to significantly higher SNR and CNR performance than with 0.025 mmol/kg. Quantitatively, a 10-min delay may be feasible for hepatobiliary-phase imaging when using 0.05 mmol/kg of gadoxetic acid.

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“…A bolus injection of gadoxetic acid provides a dual mode of action that allows imaging in the early dynamic phase (as with standard gadolinium chelates) and in the delayed phase (hepatobiliary phase) that is obtained 10 to 20 min after injection and lasts until 90 min after injection (7,8). In the hepatobiliary phase, malignant hepatic lesions lacking normally functioning hepatocytes are imaged as a defect of hepatocyte-selective enhancement as compared to the normal parenchyma (9).…”

mentioning

confidence: 99%

Comparison between areas with Gd‐EOB‐DTPA uptake and without in hepatocellular carcinomas on Gd‐EOB‐DTPA‐enhanced hepatobiliary‐phase MR imaging: Pathological correlation

Lee

Kim

Park

et al. 2010

Magnetic Resonance Imaging

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Purpose: To determine histological and MR imaging differences between areas with Gd-EOB-DTPA (gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid) uptake and without in hepatocellular carcinomas (HCCs) as seen on Gd-EOB-DTPA-enhanced hepatobiliary-phase MR images. Materials and Methods:This study included nine patients with nine histopathologically proven HCCs (mean size, 1.9 cm) that consisted of two portions of a non-hypointense (Gd-EOB-DTPA uptake) and hypointense area (no Gd-EOB-DTPA uptake) in one tumor as depicted on hepatobiliary-phase MR images. Two radiologists and one pathologist compared the histological and MR finding differences between the two portions in consensus.Results: In eight specimens, non-hypointense areas of six specimens showed a green color and two specimens did not show a green color. Microscopically, two of nine showed a higher percentage of bile pigments in the nonhypointense area as compared to the hypointense area and the remaining seven showed no difference. Six were homogeneous Edmondson-Steiner grade II, and one was grade I. In two, non-hypointense areas were grade II and hypointense areas were grade I. No difference between the two portions was found for necrosis, hemorrhage, fibrosis, and a fibrous capsule. Seven on T1/T2-weighted images and eight on arterial and portal phase images showed no different signal intensity between the two portions. Conclusion:Although macroscopically, a non-hypointense area of an HCC seen on GD-EOB-DTPA-enhanced hepatobiliary-phase images may be associated with the area with a green color, no definite microscopic and MR imaging findings that could discriminate a non-hypointense from a hypointense area of an HCC was found.

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Phase II clinical evaluation of Gd-EOB-DTPA: dose, safety aspects, and pulse sequence.

Abstract: Gd-EOB-DTPA is an efficient, diagnostically useful, and safe contrast agent.

Cited by 284 publications

References 0 publications

Dynamic contrast‐enhanced magnetic resonance imaging of abdominal solid organ and major vessel: Comparison of enhancement effect between Gd‐EOB‐DTPA and Gd‐DTPA

Dynamic contrast‐enhanced magnetic resonance imaging of abdominal solid organ and major vessel: Comparison of enhancement effect between Gd‐EOB‐DTPA and Gd‐DTPA

Intraindividual Crossover Comparison of Gadoxetic Acid Dose for Liver MRI in Normal Volunteers

Comparison between areas with Gd‐EOB‐DTPA uptake and without in hepatocellular carcinomas on Gd‐EOB‐DTPA‐enhanced hepatobiliary‐phase MR imaging: Pathological correlation

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