The Clinical Application Study Of Hepatobiliary Specific Contrast Agent Gd-EOB-DTPA

Part OneThe Application of Gd-EOB-DTPA Enhanced Magnetic Resonance Imaging in Focal Hepatic LesionsObjective To evaluate the detection efficacy of Gd-EOB-DTPA enhanced MRI in focal hepatic lesions compared with non-enhanced MRI and routine enhancement CT, study the features of Gd-EOB-DTPA Enhanced MRI in typical lesions,to increase the accuracy of detection and diagnosis in focal hepatic lesions.Materials and Methods From July 2007 to August 2008,a total 34 patients(male 27, female 7) with known or suspected focal hepatic lesions underwent precontrast (T₂-weighted,WI sequence with fat suppression,T₁WI sequences with and without fat suppression,),Gd-EOB-DTPA dynamic enhancement(T₁WI sequence with fat suppression) and delayed hepatocyte-phase MRI scanning after 20 minutes(T₁WI sequence with fat suppression,T₂WI sequence with fat suppression).Dynamic enhancement MRI included arterial phase,portal phase and equilibrium phase.A routine dual-phase multi-slice spiral CT was acquired within 4 weeks before or after MRI.The number of lesions detected,livers enhancement,lesions enhancement and lesion-liver contrast to noise ratios(CNR) were calculated and quantitative analyzed. The features of Gd-EOB-DTPA Enhanced MRI in typical lesions were studied.Results A total of 96 lesions in 34 cases were verified.Liver signal intensity and the absolute value of leison-liver CNR were remarkably increased(P＜0.001).There were 95 lesions on Gd-EOB-DTPA enhancement sequences(dynamic enhancement and hepatocyte-phase),83 lesions were respectively found on precontrast T₁WI and T₂WI sequences as well as 72 by routine enhancement CT.There were significant differences between Gd-EOB-DTPA enhancement sequences and precontrast sequences also routine enhancement CT(P＜0.001).In the detection of micro-lesions (＜1.0 cm),compared with precontrast T₁WI and routine enhancement CT, Gd-EOB-DTPA enhancemet sequences highly improved the proportion with statistical significance(P=0.004 and P＜0.001),there was also difference between Gd-EOB-DTPA enhancemet sequences and precontrast T₂WI,but no significant difference.The detection rates of lesions from 1 to 3 centimeters were significantly different between Gd-EOB-DTPA enhancement sequences and precontrast T₂WI as well as routine enhancement CT(P=0.016 and P=0.004),there was no statistically significant between Gd-EOB-DTPA enhancemet sequences and precontrast T₁WI.So Gd-EOB-DTPA enhancement sequences improved the detection rate of focal liver lesions significantly.Excluding cysts,characters of 70 lesions were confirmed, including 16 hepatocellular carcinomas,1 cholangio carcinoma,37 hepatic metastases, 9 hemangiomas,1 dysplastic nodules,1 focal nodular hyperplasia,1 adenoma,3 inflammatory pseudotumors and 1 lymphoepithelioma-like carcinoma. Gd-EOB-DTPA dynamic enhancement phases showed the similar enhancement pattern with routine enhancement MRI.During the hepatocyte-phase,1 hepatocellular carcinoma showed relatively high signal,other hepatocellular carcinomas,cholangio carcinoma,hepatic metastases,lymphoepithelioma-like carcinoma,dysplastic nodules, adenoma,hemangiomas and inflammatory pseudotumors all showed low signal,focal nodular hyperplasia was an slightly high signal lesion.Conclusion Gd-EOB-DTPA enhancement MRI has the ability that could increase the detection rate of focal liver lesions.Gd-EOB-DTPA dynamic enhancement combined with hepatocyte-phase scanning were able to provide more diagnosis information and to improve the confidence in dignosis.Part Two The Application of Gd-EOB-DTPA in Contrast-enhanced Magnetic Resonance CholangiographyObjective To quantitate the change of intrabiliary signal intensity before and 30 minutes after Gd-EOB-DTPA injection,compare the degree of biliary visualization of Gd-EOB-DTPA-enhanced Magnetic Resonance cholangiography(EOB-MRC) with Magnetic Resonance cholangiopancreatography(MRCP),evaluate the ability and characteristics of Gd-EOB-DTPA in depicting biliary structures preliminarily.Materials and Methods 16 patients from part one(male 15,female 1) with known hepatic masses but without known biliary disease or surgery history were enrolled.All patients underwent MRCP precontrast and EOB-MRC using 3D GRE T₁WI(3D VIBE) with fat suppression and 3D fast low-angle shot(FLASH) GRE T₁WI with fat suppression 30 minitues after Gd-EOB-DTPA injection.Signal intensity of liver parenchyma and that in the common bile duct(CBD) as well as gallbladder(GB) were measured,duct-liver contrast to noise ratios(CNR) were calculated and quantitative analyzed.Biliary visualization of MRCP and EOB-MRC was qualitatively assessed by using a Likert 5-point scale respectively and paired.Results Signal intensity in the common bile duct before and 30 minutes after Gd-EOB-DTPA injection was 113.27±38.20 and 595.31±34.62,that of gallbladder was 182.73±113.45 and 684.20±153.41.CBD-liver CNR was -131.13±33.29 and 74.53±66.02 before and 30 minutes injection,GB-liver CNR was -66.06±96.06 and 117.08±68.48.There were significant differences between precontrast and that after injection(P＜0.001).Visualization rating of common bile duct,common hepatic duct, left hepatic duct and right hepatic duct using EOB-MRC and MRCP showed no statistically significant,rating was improved by using paired of MRCP and EOB-MRC,but there were also no statistically significant among paired and unpaired. Visualization rating of gallbladder for EOB-MRC and MRCP was 3.09±1.00 and 3.76±0.44,paired was 3.82±0.39,showed statistically significant among paired and unpaired(P＜0.01).For second-order division intrahepatic bile ducts,paired of MRCP and EOB-MRC(2.59±1.22) improved visualization rating significantly(P＜0.05), the rating of EOB-MRC(2.25±1.33) was higher than that of MRCP(1.67±1.33),but no significant difference.Conclusion EOB-MRC performed satisfyingly in depicting all biliary structures except some gallbladders,the rating for second-order division intrahepatic bile ducts of EOB-MRC was higher than that of MRCP,visualization of other structures showed no statistically significant between EOB-MRC and MRCP.EOB-MRC and MRCP complemented each other,the combination of them could provide more diagnosis information and increase the confidence in dignosis.Part Three Safety Evaluation of Clinical Application of Gd-EOB-DTPAObjective To evaluate the safety of Gd-EOB-DTPA by observing side effects,adverse events and changes of vital signs as well as laboratory examinations during the period before and 24 hours after the application of Gd-EOB-DTPA.Materials and Methods The patients in part one were observed and monitored carefully.The items included physical examinations before and 24 hours after MRI examination,monitoring vital signs by measurements of blood pressure and heart rate at multiple time points(before,5 minutes after injection of Gd-EOB-DTPA, immediately and 24 hours after finishing MRI examination),taking laboratory examinations(blood and urine routine tests,liver and kidney function tests,blood electrolyte and glucose,blood lipid and blood amylase) before and 24 hours after the injection of Gd-EOB-DTPA.Results No side effect or adverse event in any of 34 patients was observed.There were no discomfort complaint and no significant changes in vital signs or results of laboratory examinations(blood and urine routine tests,liver and kidney function tests,blood electrolyte and glucose,blood lipid and blood amylase) afterâ…£administration of Gd-EOB-DTPA.Conclusion Gd-EBO-DTPA is a kind of hepatobiliary specific contrast agent with low toxicity and high safety.