A Phase 3 Multicentre, Randomised, Comparative Study of the Efficacy and Safety of Sonazoid and SonoVue in Subjects with Focal Liver Lesions Undergoing Pre- and Post-Contrast Ultrasound Imaging

2017 ◽  
Vol 43 ◽  
pp. S34-S35 ◽  
Author(s):  
Yuxin Jiang ◽  
Ke Lv ◽  
Ping Liang ◽  
Huixiong Xu ◽  
Lianfang Du ◽  
...  
Keyword(s):  
Comparative Study ◽  
Ultrasound Imaging ◽  
Focal Liver Lesions ◽  
Liver Lesions ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Post Contrast ◽  
Contrast Ultrasound

scholarly journals Diagnostic Efficacy and Safety of Gadoxetate Disodium vs Gadobenate Dimeglumine in Patients With Known or Suspected Focal Liver Lesions: Results of a Clinical Phase III Study

2019 ◽  
Vol 12 ◽  
pp. 1178623X1982797
Author(s):  
Christoph J Zech ◽  
Carsten Schwenke ◽  
Jan Endrikat
Keyword(s):  
Sensitivity And Specificity ◽  
Gadobenate Dimeglumine ◽  
Phase Iii ◽  
Focal Liver Lesions ◽  
Liver Lesions ◽  
Efficacy And Safety ◽  
Gadoxetate Disodium ◽  
Diagnostic Efficacy ◽  
Post Contrast ◽  
Phase Iii Study

Purpose: The aim of this study is to evaluate the diagnostic efficacy and safety of gadoxetate disodium vs gadobenate dimeglumine in patients with known or suspected focal liver lesions. Methods: This was a prospective, multicenter, double-blind, randomized, inter-individual Phase III study. The primary target—technical efficacy—was already published. Here, secondary efficacy parameters—sensitivity and specificity—and safety in specific patient populations are presented. Patients with suspected or known focal liver lesions scheduled for contrast-enhanced liver magnetic resonance imaging (MRI) were recruited and categorized in 4 a priori specified subgroups: (1) all patients, (2) patients with liver cancer (hepatocellular carcinoma [HCC]), (3) patients with cirrhosis, and (4) patients with HCC + cirrhosis. Dual multi-detector liver computed tomography (CT) served as standard of reference. Results: A total of 295 patients were included. While the overall increase in sensitivity across all 4 patient groups was comparable for gadoxetate disodium (increase from pre- to post-contrast ranging from 6.2% to 9.9%) and gadobenate dimeglumine (ranging from −2.9% to 10.0%), significant differences were seen for some of the subgroups. There was a significantly higher increase in sensitivity for gadoxetate disodium in patients with HCC (7%) and HCC + cirrhosis (12.8%) in comparison with gadobenate dimeglumine. Specificity decreased for both agents: gadoxetate disodium by −2.8% to −6.3% and gadobenate dimeglumine by −3.3% to −8.7%. Gadoxetate showed a significantly lower loss of specificity in all subgroups. Safety was comparable in both groups. Conclusions: Gadoxetate disodium proved to be an effective liver-specific MRI contrast agent. Some distinct advantages over gadobenate dimeglumine were demonstrated in patients with HCC and patients with HCC + liver cirrhosis for sensitivity and specificity in liver lesion detection.

Real-time Contrast-Enhanced Ultrasound Imaging of Infected Focal Liver Lesions

2008 ◽  
Vol 27 (4) ◽  
pp. 657-666 ◽  
Author(s):  
Guang-Jian Liu ◽  
Ming-De Lu ◽  
Xiao-Yan Xie ◽  
Hui-Xiong Xu ◽  
Zuo-Feng Xu ◽  
...  
Keyword(s):  
Real Time ◽  
Ultrasound Imaging ◽  
Focal Liver Lesions ◽  
Liver Lesions ◽  
Contrast Enhanced Ultrasound ◽  
Contrast Enhanced

Efficacy and safety of IBI305 compared with bevacizumab in advanced non-squamous NSCLC patients as first-line treatment in a randomized, double-blind, phase III study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9095-9095
Author(s):  
Li Zhang ◽  
Bin Wu ◽  
Linian Huang ◽  
Meiqi Shi ◽  
Yunpeng Liu ◽  
...  
Keyword(s):  
Comparative Study ◽  
Maintenance Treatment ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Phase 3 ◽  
Double Blind ◽  
Nsclc Patients ◽  
Equivalence Margin ◽  
First Line Treatment

9095 Background: IBI305 is a recombinant humanized anti-VEGF monoclonal antibody, a biosimilar candidate to bevacizumab in analytical and functional comparisons. Pharmacokinetic similarity has been demonstrated in healthy males. Here we present primary efficacy and safety results from a phase 3 comparative study in non-small cell lung cancer (NSCLC). Methods: In this double-blind, active-controlled study, subjects with advanced non-squamous NSCLC on first-line treatment with carboplatin and paclitaxel were randomized (1:1) to IBI305 or bevacizumab (15 mg/kg IV Q3W). After six cycles, patients were on maintenance treatment with IBI305 or bevacizumab (7.5 mg/kg IV Q3W) till progression. Clinical equivalence of the primary endpoint, confirmed objective response rate (ORR) was evaluated by comparing the 2-sided 90% confidence interval (CI) of the risk ratio (RR) between study arms with the prespecified margin (0.75, 1.33). Results: A total of 450 subjects were randomized (IBI305: n = 224; bevacizumab: n = 226). Baseline characteristics were well balanced between treatment arms. ORR evaluated by Independent Radiological Review Committee (IRRC) in full analysis set (FAS) was 44.3% (98/221) for IBI305 and 46.4% (102/220) for bevacizumab; the RR for ORR was 0.95 (90% CI: 0.803, 1.135). Sensitive analysis result on RRs of ORR in Intention to Treat (ITT) population (IBI305: n = 224; bevacizumab: n = 226) and other analysis set were consistent and all within the prespecified equivalence margin. The medium PFS were 8.4 months for IBI305 and 8.3 months for bevacizumab and duration of response (DOR) was also similar in both arms. Treatment-emergent adverse events (TEAEs) were well balanced between treatment arms and consistent with the known adverse event profile of bevacizumab. Patients developing binding antibodies were 0.5% in the IBI305 arm vs 0% in the bevacizumab arm; no subject tested positive for neutralizing antibodies. Conclusions: This is the first released phase 3 clinical study with maintenance treatment for bevacizumab biosimilar in NSCLC patients till now. The comparative study met its predefined primary endpoint that the RR for confirmed ORR was within the prespecified equivalence margin. There was no significant difference between the two arms in safety profile and immunogenicity. Clinical trial information: NCT02954172.

Phased array breath-hold versus non-breath-hold MR imaging of focal liver lesions: A prospective comparative study

1997 ◽  
Vol 7 (2) ◽  
pp. 292-297 ◽  
Author(s):  
Yasuyuki Yamashita ◽  
Hiroaki Yamamoto ◽  
Tomohiro Namimoto ◽  
Yasuko Abe ◽  
Mutsumasa Takahashi
Keyword(s):  
Mr Imaging ◽  
Comparative Study ◽  
Phased Array ◽  
Breath Hold ◽  
Focal Liver Lesions ◽  
Liver Lesions ◽  
Prospective Comparative Study

scholarly journals Diagnostic Accuracy of Delayed Phase Post Contrast Computed Tomographic Images in the Diagnosis of Focal Liver Lesions in Dogs: 69 Cases

2021 ◽  
Vol 8 ◽  
Author(s):  
Silvia Burti ◽  
Alessandro Zotti ◽  
Federico Bonsembiante ◽  
Barbara Contiero ◽  
Tommaso Banzato
Keyword(s):  
Machine Learning ◽  
Decision Tree ◽  
Normal Liver ◽  
Focal Liver Lesions ◽  
Liver Lesions ◽  
Quantitative Ct ◽  
Post Contrast ◽  
Surface Appearance ◽  
Computed Tomographic ◽  
Ct Features

To describe the computed tomographic (CT) features of focal liver lesions (FLLs) in dogs, that could enable predicting lesion histotype. Dogs diagnosed with FLLs through both CT and cytopathology and/or histopathology were retrospectively collected. Ten qualitative and 6 quantitative CT features have been described for each case. Lastly, a machine learning-based decision tree was developed to predict the lesion histotype. Four categories of FLLs - hepatocellular carcinoma (HCC, n = 13), nodular hyperplasia (NH, n = 19), other benign lesions (OBL, n = 18), and other malignant lesions (OML, n = 19) - were evaluated in 69 dogs. Five of the observed qualitative CT features resulted to be statistically significant in the distinction between the 4 categories: surface, appearance, lymph-node appearance, capsule formation, and homogeneity of contrast medium distribution. Three of the observed quantitative CT features were significantly different between the 4 categories: the Hounsfield Units (HU) of the radiologically normal liver parenchyma during the pre-contrast scan, the maximum dimension, and the ellipsoid volume of the lesion. Using the machine learning-based decision tree, it was possible to correctly classify NHs, OBLs, HCCs, and OMLs with an accuracy of 0.74, 0.88, 0.87, and 0.75, respectively. The developed decision tree could be an easy-to-use tool to predict the histotype of different FLLs in dogs. Cytology and histology are necessary to obtain the final diagnosis of the lesions.

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