Incidence and Severity of Acute Adverse Reactions to Four Different Gadolinium-based MR Contrast Agents

Okigawa, Takashi; Utsunomiya, Daisuke; Tajiri, Satomi; Okumura, Shuichiro; Sasao, Akira; Wada, Hirohumi; Oda, Shigeto; Arimura, Hiroki; Hayashida, Eri; Urata, Joji; Yamashita, Yasuyuki

doi:10.2463/mrms.2012-0051

Cited by 22 publications

(17 citation statements)

References 13 publications

(16 reference statements)

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“…1,2 Its pharmacokinetics is similar to that of extracellular contrast agents immediately after bolus injection; it is taken up rapidly into hepatocytes and subsequently excreted into bile. Recent studies have demonstrated important advantages of gadoxetic acid-enhanced MR imaging over other methods for imaging liver disease.…”

Section: Introductionmentioning

confidence: 99%

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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Section: Introductionmentioning

confidence: 99%

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

Bannas

Hernando

Rahimi

et al. 2016

MRMS

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“…Several reports have raised concerns regarding the use of GBCA because of the occurrence of nephrogenic systemic fibrosis (NSF) and acute, immediate adverse reactions after IV administration of GBCA . However, the majority of these reports were retrospective so that the actual incidence of AEs along with that of NSF has not been fully addressed, or were based on single‐site or single‐country practices.…”

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confidence: 99%

Observational study on the safety profile of gadoterate meglumine in 35,499 patients: The SECURE study

Soyer

Dohan

Patkar

et al. 2016

Magnetic Resonance Imaging

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Purpose: To investigate the safety of gadoterate meglumine and identify the incidence of nephrogenic systemic fibrosis (NSF). Materials and Methods: An international prospective observational study was conducted from November 2008 to June 2013. A total of 35,499 adults and children who were scheduled to undergo contrast-enhanced MRI using gadoterate meglumine were analyzed (female, 53.1%; mean age: 49.5 years; range: 0-98 years). At least 3-month follow-up was planned for patients with an estimated creatinine clearance or glomerular filtration rate <60 mL/min (/1.73 m2) to detect any suspicion or occurrence of NSF. Adverse events (AEs) were prospectively recorded. Demographic data, risk factors, indications for MRI examinations, characteristics of gadoterate meglumine administration, and efficacy were documented. Results: MRI examinations were mainly for central nervous system (61%). The most frequent risk factor was renal insufficiency (14.7%). Seventy AEs were observed in 44 patients (0.12%). Among the 70 AEs, 38 in 32 patients (0.09% of all patients) were considered related to gadoterate meglumine and classified as adverse drug reaction (ADR).The most frequent ADRs were urticaria (9 patients, 0.03%), nausea (7 patients, 0.02%), and vomiting (4 patients, 0.01%). Within the pediatric population (1,629 patients), only one AE (vomiting) was observed. Nine adult patients (0.03%) experienced serious AEs. Moderate to severe renal insufficiency at inclusion was reported in 514 patients (1.5%). Among them, 476 (92.6%) were followed-up. No patients were suspected of having NSF and no cases of NSF were observed. Conclusion: Our study confirms the excellent safety profile of gadoterate meglumine in routine practice. Level of Evidence: 1

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“…However, it is known that the combination of DCE-MRI and DWI improves the detectability and provides additional information to characterize liver lesions[10-12,37,38]. DWI thus plays an important role in the assessment of liver tumors for patients with contrast-agent contraindications, such as renal failure or a history of adverse reaction to a contrast agent[38,39]. DWI has also been applied for other evaluations of HCCs, such as for assessment of the treatment effects of TACE and molecular target therapy[40,41].…”

Section: Discussionmentioning

confidence: 99%

Image quality and diagnostic performance of free-breathing diffusion-weighted imaging for hepatocellular carcinoma

Takayama

Nishie

Asayama

et al. 2017

WJH

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AIMTo retrospectively evaluate the diagnostic performance of free-breathing diffusion-weighted imaging (FB-DWI) with modified imaging parameter settings for detecting hepatocellular carcinomas (HCCs).METHODSFifty-one patients at risk for HCC were scanned with both FB-DWI and respiratory-triggered DWI with the navigator echo respiratory-triggering technique (RT-DWI). Qualitatively, the sharpness of the liver contour, the image noise and the chemical shift artifacts on each DWI with b-values of 1000 s/mm2 were independently evaluated by three radiologists using 4-point scoring. We compared the image quality scores of each observer between the two DWI methods, using the Wilcoxon signed-rank test. Quantitatively, we compared the signal-to-noise ratios (SNRs) of the liver parenchyma and lesion-to-nonlesion contrast-to-noise ratios (CNRs) after measuring the signal intensity on each DWI with a b-factor of 1000 s/mm2. The average SNRs and CNRs between the two DWI methods were compared by the paired t-test. The detectability of HCC on each DWI was also analyzed by three radiologists. The detectability provided by the two DWI methods was compared using McNemar’s test.RESULTSFor all observers, the averaged image quality scores of FB-DWI were: Sharpness of the liver contour [observer (Obs)-1, 3.08 ± 0.81; Obs-2, 2.98 ± 0.73; Obs-3, 3.54 ± 0.75], those of the distortion (Obs-1, 2.94 ± 0.50; Obs-2, 2.71 ± 0.70; Obs-3, 3.27 ± 0.53), and the chemical shift artifacts (Obs-1, 3.38 ± 0.60; Obs-2, 3.15 ± 1.07; Obs-3, 3.21 ± 0.85). The averaged image quality scores of RT-DWI were: Sharpness of the liver contour (Obs-1, 2.33 ± 0.65; Obs-2, 2.37 ± 0.74; Obs-3, 2.75 ± 0.81), distortion (Obs-1, 2.81 ± 0.56; Obs-2, 2.25 ± 0.74; Obs-3, 2.96 ± 0.71), and the chemical shift artifacts (Obs-1, 2.92 ± 0.59; Obs-2, 2.21 ± 0.85; Obs-3, 2.77 ± 1.08). All image quality scores of FB-DWI were significantly higher than those of RT-DWI (P < 0.05). The average SNR of the normal liver parenchyma by FB-DWI (11.0 ± 4.8) was not significantly different from that shown by RT-DWI (11.0 ± 5.0); nor were the lesion-to-nonlesion CNRs significantly different (FB-DWI, 21.4 ± 17.7; RT-DWI, 20.1 ± 15.1). For all three observers, the detectability of FB-DWI (Obs-1, 43.6%; Obs-2, 53.6%; and Obs-3, 45.0%) was significantly higher than that of RT-DWI (Obs-1, 29.1%; Obs-2, 43.6%; and Obs-3, 34.5%) (P < 0.05).CONCLUSIONFB-DWI showed better image quality and higher detectability of HCC compared to RT-DWI, without significantly reducing the SNRs of the liver parenchyma and lesion-to-nonlesion CNRs.

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Incidence and Severity of Acute Adverse Reactions to Four Different Gadolinium-based MR Contrast Agents

Cited by 22 publications

References 13 publications

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

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

Observational study on the safety profile of gadoterate meglumine in 35,499 patients: The SECURE study

Image quality and diagnostic performance of free-breathing diffusion-weighted imaging for hepatocellular carcinoma

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