Best Practice Guideline - DEGUM Recommendations on Breast Ultrasound. / Best Practice Guideline ­ Empfehlungen der DEGUM zur Durchführung und Beurteilung der Mammasonografie.

Alongside mammography, breast ultrasound is an important and well-established method in assessment of breast lesions. With the "Best Practice Guideline", the DEGUM Breast Ultrasound (in German, "Mammasonografie") working group, intends to describe the additional and optional application modalities for the diagnostic confirmation of breast findings and to express DEGUM recommendations in this Part II, in addition to the current dignity criteria and assessment categories published in Part I, in order to facilitate the differential diagnosis of ambiguous lesions.The present "Best Practice Guideline" has set itself the goal of meeting the requirements for quality assurance and ensuring quality-controlled performance of breast ultrasound. The most important aspects of quality assurance are explained in this Part II of the Best Practice Guideline.

Best Practice Guideline - DEGUM Recommendations on Breast Ultrasound. / Best Practice Guideline ­ Empfehlungen der DEGUM zur Durchführung und Beurteilung der Mammasonografie ­ TEIL I ­ Untersuchungstechnik, Ultraschall-DEGUM-Kriterien und deren Dokumentation.

For many years, breast ultrasound has been used in addition to mammography as an important method for clarifying breast findings. However, differences in the interpretation of findings continue to be problematic 1 2. These differences decrease the diagnostic accuracy of ultrasound after detection of a finding and complicate interdisciplinary communication and the comparison of scientific studies 3. In 1999, the American College of Radiology (ACR) created a working group (International Expert Working Group) that developed a classification system for ultrasound examinations based on the established BI-RADS classification of mammographic findings under consideration of literature data 4. Due to differences in content, the German Society for Ultrasound in Medicine (DEGUM) published its own BI-RADS-analogue criteria catalog in 2006 3. In addition to the persistence of differences in content, there is also an issue with formal licensing with the current 5th edition of the ACR BI-RADS catalog, even though the content is recognized by the DEGUM as another system for describing and documenting findings. The goal of the Best Practice Guideline of the Breast Ultrasound Working Group of the DEGUM is to provide colleagues specialized in senology with a current catalog of ultrasound criteria and assessment categories as well as best practice recommendations for the various ultrasound modalities.

A Giant Mammary Hamartoma in a Young Breast Cancer Patient.

BACKGROUND: Hamartomas of the breast are rare benign tumors. Pre- and also postoperative differentiation from other benign or even malignant tumors is challenging. CASE PRESENTATION: A 36-year-old female presented with a giant tumor of the left breast. The patient had suffered from an early breast cancer of the contralateral right breast the year before, which was treated with breast-conserving therapy, radiation, and endocrine therapy ever since. The hamartoma was classified as BI-RADS 2 in mammography and BI-RADS 4 in ultrasound. On clinical examination, a tumor of nearly 15 cm in size led to an abstruse deformity of the breast and the nipple-areola complex. We found an indolent, grand bulging tumor with an elastic texture directly beneath the skin. A biopsy that had been performed before was compatible with the suspected hamartoma. Because of the remaining diagnostic uncertainties after contralateral breast cancer and the progressive malformation of the left breast, a tumor extirpation utilizing a reduction mammaplasty was performed without complications. Subsequent genetic analyses excluded a loss of PTEN in this patient. CONCLUSION: We presented the rare case of a 36-year-old woman with a history of breast cancer and a 700-g breast hamartoma. The preoperative and even the postoperative specification of a hamartoma remains challenging, and associations with genetic alterations should be considered.

Accuracy of tumor size measurement: comparison of B-mode ultrasound, strain elastography, and 2D and 3D shear wave elastography with histopathological lesion size.

BACKGROUND: Predicting the exact extent of a breast tumor is of great importance for oncologic treatment strategies. Different types of elastography can be used as new tools for measuring lesion size. PURPOSE: To provide evidence regarding the accuracy of tumor size measurement of strain elastography (SE), two-dimensional (2D) and three-dimensional (3D) shear wave elastography (SWE), and conventional B-image ultrasound. MATERIAL AND METHODS: In this prospective study, the diameter of 105 malignant breast lesions was measured by SE, 2D and 3D SWE, and B-mode ultrasound. The histopathological lesion size was compared to all imaging-based measuring methods. RESULTS: The mean lesion size of all breast carcinomas was 1.54 cm. B-mode ultrasound underestimates breast cancer size in 65.7 % of all cases in this study ( P < 0.0001). Mean lesion size was more accurately determined by SE, 2D and 3D SWE compared to B-mode ultrasound. Absolute differences between measured and actual lesion are smaller for B-mode ultrasound (0.26 cm) than for SE (0.41 cm) and 2D and 3D SWE (0.41 cm and 0.44 cm, respectively). CONCLUSION: B-mode ultrasound allows more accurate lesion size measurement than SE and 2D or 3D SWE but has a significantly higher risk of underestimating tumor size which could lead to incomplete margins during surgery. 3D SWE was not superior to 2D SWE or SE but by trend more precise in predicting the size of invasive lobular carcinoma.

A Prospective Two Center Study Comparing Breast Cancer Lesion Size Defined by 2D Shear Wave Elastography, B-Mode Ultrasound, and Mammography with the Histopathological Size.

PURPOSE: The aim of the present study was to determine the accuracy of breast cancer measurement with 2 D shear wave elastography (2 D SWE), B-mode ultrasound, and mammography by comparing these methods with the actual histopathological tumor size. MATERIALS AND METHODS: 135 patients with proven malignant breast lesions at two centers were included in a prospective study. The maximum lesion diameter was measured by 2 D SWE, B-mode ultrasound, and mammography. After surgery, the histopathological tumor size was measured by a pathologist. RESULTS: The mean difference in tumor size on 2 D SWE, B-mode ultrasound, and mammography on the one hand, and the actual tumor size on the other, was -0.03 cm, 0.16 cm and 0.10 cm, respectively. Lesion size on histopathological investigation was overestimated by 2 D SWE (p = 0.004) and underestimated by B-mode imaging (p < 0.001). All three imaging methods underestimated the size of invasive lobular cancers and lesions > 15 mm; 2 D SWE was most accurate in this regard. CONCLUSION: 2 D SWE predicted lesion size more precisely than B-mode ultrasound or mammography. In cases of invasive lobular carcinoma, all three imaging methods underestimated lesion size, with 2 D SWE coming closest to the actual tumor size.

SOFIA: A Novel Automated Breast Ultrasound System Used on Patients in the Prone Position: A Pilot Study on Lesion Detection in Comparison to Handheld Grayscale Ultrasound.

INTRODUCTION: Most of the currently available automated breast ultrasound systems require patients to be in the supine position. Previous data, however, show a high recall rate with this method due to artifacts. The novel automated breast ultrasound scanner SOFIA scans the breast with the patient in a prone position, resulting in even compression of breast tissue. We present our initial results with this examination method. MATERIAL AND METHODS: 63 patients were analyzed using a handheld B-mode ultrasound. In cases of BI-RADS 1, 2 or 5, a SOFIA scan was performed. Sensitivity, specificity and accuracy were calculated. Interobserver agreement was evaluated using Cohen's kappa. The duration of the scan was measured for both methods. RESULTS: No BI-RADS 5 lesion was missed with SOFIA. The SOFIA had an additional recall rate of 16.67% compared to B-mode ultrasound. The sensitivity, specificity and accuracy of SOFIA was 100, 83.33 and 88.89%, respectively. Cohen's kappa showed substantial agreement (κ = 0.769) between examiner 1 (B-mode) and examiner 2 (SOFIA). The mean scan duration for the B-mode system and the SOFIA system was 24.21 minutes and 12.94 minutes, respectively. In four cases, D-cup breasts were not scanned in their entirety. CONCLUSION: No cancer was missed when SOFIA was used in this preselected study population. The scanning time was approximately half of that required for B-mode ultrasound. The additional unnecessary recall rate was 16.67%. Larger D cup-size breasts were difficult to position and resulted in an incomplete image in four cases.

Radiological imaging characteristics of intramammary hematological malignancies: results from a german multicenter study.

To assess radiological procedures and imaging characteristics in patients with intramammary hematological malignancies (IHM). Radiological imaging studies of histopathological proven IHM cases from ten German University affiliated breast imaging centers from 1997-2012 were retrospectively evaluated. Imaging modalities included ultrasound (US), mammography and magnetic resonance imaging (MRI). Two radiologists blinded to the histopathological diagnoses independently assessed all imaging studies. Imaging studies of 101 patients with 204 intramammary lesions were included. Most patients were women (95%) with a median age of 64 years. IHM were classified as Non Hodgkin lymphoma (77.2%), plasmacytoma (11.9%), leukemia (9.9%), and Hodgkin lymphoma (1%). The mean lesion size was 15.8 ± 10.1 mm. Most IHM presented in mammography as lesions with comparable density to the surrounding tissue, and a round or irregular shape with indistinct margins. On US, most lesions were of irregular shape with complex echo pattern and indistinct margins. MRI shows lesions with irregular or spiculated margins and miscellaneous enhancement patterns. Using US or MRI, IHM were more frequently classified as BI-RADS 4 or 5 than using mammography (96.2% and 89.3% versus 75.3%). IHM can present with miscellaneous radiological patterns. Sensitivity for detection of IHM lesions was higher in US and MRI than in mammography.

Imaging findings of primary breast sarcoma: Results of a first multicenter study.

PURPOSE: To investigate imaging findings in patients with primary breast sarcoma (PBS). MATERIALS AND METHODS: A retrospective search in the databases of 10 radiological departments in Germany from 2000 to 2011 was performed. Only histologically proven cases of PBS were included into the study. Mammography was available in 31 patients (33 lesions), ultrasound images in 24 patients (24 lesions), and for 10 patients (14 lesions) magnetic resonance imaging (MRI) of the breast was performed. The breast findings were classified according to the American College of Radiology Breast Imaging Reporting and Data Systems (BI-RADS) 5th edition categories. Collected data were evaluated by means of descriptive statistics. RESULTS: Forty-two female patients (mean age 62.0 years, range, 30-86 years) were included in the study. Clinically, all women had painless lumps. Irregular (53.3% [16/30]) or oval (30.0% [9/30]) mass with indistinct (73.3% [22/30]) or microlobulated (10% [3/30]) margins were common findings on mammograms. Ultrasound revealed typically an irregular (79.2% [19/24]), hypoechoic (62.5% [15/24]) mass, with indistinct margins (79.2% [19/24]), and posterior acoustic shadowing (79.2% [19/24]). MRI showed irregular masses (81.8% [9/11]) with irregular or spiculated margins, and a rapid initial signal increase with a delayed washout in kinetic analysis. CONCLUSION: Overall, PBS has no pathognomonic imaging features and can mimic those of invasive mammary carcinoma. Breast sarcoma should be taken into the differential diagnosis of breast findings described above.

WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology.

Conventional diagnostic ultrasound images of the anatomy (as opposed to blood flow) reveal differences in the acoustic properties of soft tissues (mainly echogenicity but also, to some extent, attenuation), whereas ultrasound-based elasticity images are able to reveal the differences in the elastic properties of soft tissues (e.g., elasticity and viscosity). The benefit of elasticity imaging lies in the fact that many soft tissues can share similar ultrasonic echogenicities but may have different mechanical properties that can be used to clearly visualize normal anatomy and delineate pathologic lesions. Typically, all elasticity measurement and imaging methods introduce a mechanical excitation and monitor the resulting tissue response. Some of the most widely available commercial elasticity imaging methods are 'quasi-static' and use external tissue compression to generate images of the resulting tissue strain (or deformation). In addition, many manufacturers now provide shear wave imaging and measurement methods, which deliver stiffness images based upon the shear wave propagation speed. The goal of this review is to describe the fundamental physics and the associated terminology underlying these technologies. We have included a questions and answers section, an extensive appendix, and a glossary of terms in this manuscript. We have also endeavored to ensure that the terminology and descriptions, although not identical, are broadly compatible across the WFUMB and EFSUMB sets of guidelines on elastography (Bamber et al. 2013; Cosgrove et al. 2013).

WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 3: liver.

The World Federation for Ultrasound in Medicine and Biology (WFUMB) has produced these guidelines for the use of elastography techniques in liver disease. For each available technique, the reproducibility, results, and limitations are analyzed, and recommendations are given. Finally, recommendations based on the international literature and the findings of the WFUMB expert group are established as answers to common questions. The document has a clinical perspective and is aimed at assessing the usefulness of elastography in the management of liver diseases.

WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 2: breast.

The breast section of these Guidelines and Recommendations for Elastography produced under the auspices of the World Federation of Ultrasound in Medicine and Biology (WFUMB) assesses the clinically used applications of all forms of elastography used in breast imaging. The literature on various breast elastography techniques is reviewed, and recommendations are made on evidence-based results. Practical advice is given on how to perform and interpret breast elastography for optimal results, with emphasis placed on avoiding pitfalls. Artifacts are reviewed, and the clinical utility of some artifacts is discussed. Both strain and shear wave techniques have been shown to be highly accurate in characterizing breast lesions as benign or malignant. The relationship between the various techniques is discussed, and recommended interpretation based on a BI-RADS-like malignancy probability scale is provided. This document is intended to be used as a reference and to guide clinical users in a practical way.

Significance of syndecan-1 expression in ductal carcinoma in situ of the breast.

BACKGROUND: Fibroblast growth factor-2 (FGF-2) supports tumor progression in breast cancer. FGF-2 signaling is modulated by heparan sulfate proteoglycans, such as syndecan-1 (CD138). The exact role of CD138 in ductal carcinoma in situ of the breast (DCIS) is still uncertain. Differential expression depending on grading could suggest a role for syndecan-1 during growth and tumor progression. MATERIALS AND METHODS: Samples of 127 cases of breast DCIS associated with follow-up data were included. CD138 staining intensity, number of positive cells, intracellular and tissue localization were examined. RESULTS: Median follow-up was 45.4 months and median recurrence-free survival (RFS) 86 months. Age, menopausal status and previous hormone replacement therapy had no significant influence on RFS. Smoking significantly influenced RFS (p=0.008). Endocrine therapy or radiotherapy did not improve RFS. Grading was not correlated with CD138 staining intensity, but was significantly associated with the percentage of CD138-positive cells (low-vs. high-grade, p=0.043). Estrogen receptor (ER) expression did not influence staining intensity of CD138 (p=0.247), but negatively correlated with the proportion of CD138-positive cells (p=0.032). Progesterone receptor (PR) expression significantly influenced the intensity of staining (p=0.010) and the percentage of CD138-positive cells (p=0.004); both were increased in PR-negative cases. CD138 staining intensity and percentage of positive cells did not correlate with RFS. Nuclear grade and syndecan-1 staining localization were significantly associated (p=0.001). ER-positive, and PR-positive DCIS more often exhibited membrane-bound syndecan-1 than ER- or PR-negative cases (p=0.001). Nuclear grade and tissue localization of CD138 correlated significantly (p=0.005). PR influenced CD138 tissue distribution, while ER did not. Syndecan-1 localization did not statistically impact RFS. CONCLUSION: In DCIS of different nuclear grades, tissue localization of syndecan-1 is significantly divergent, suggesting a specific effect on biology and progression of DCIS.

Laparoscopic mesh-augmented hiatoplasty without fundoplication as a method to treat large hiatal hernias.

PURPOSE: Laparoscopic hiatal hernia repair with additional fundoplication is a commonly recommended standard surgical treatment for symptomatic large hiatal hernias with paraesophageal involvement (PEH). However, due to the risk of persistent side effects, this method remains controversial. Laparoscopic mesh-augmented hiatoplasty without fundoplication (LMAH), which combines hiatal repair and mesh reinforcement, might therefore be an alternative. METHODS: In this retrospective study of 55 (25 male, 30 female) consecutive PEH patients, the perioperative course and symptomatic outcomes were analyzed after a mean follow-up of 72 months. RESULTS: The mean DeMeester symptom score decreased from 5.1 to 1.8 (P < 0.001) and the gas bloating value decreased from 1.2 to 0.5 (P = 0.001). The dysphagia value was 0.7 before surgery and 0.6 (P = 0.379) after surgery. The majority of the patients were able to belch and vomit (96 and 92 %, respectively). Acid-suppressive therapy on a regular basis was discontinued in 68 % of patients. In 4 % of patients, reoperation was necessary due to recurrent or persistent reflux. A mesh-related stenosis that required endoscopic dilatation occurred in 2 % of patients. CONCLUSIONS: LMAH is feasible, safe and provides an anti-reflux effect, even without fundoplication. As operation-related side effects seem to be rare, LMAH is a potential treatment option for large hiatal hernias with paraesophageal involvement.

Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses.

PURPOSE: To determine whether adding shear-wave (SW) elastographic features could improve accuracy of ultrasonographic (US) assessment of breast masses. MATERIALS AND METHODS: From September 2008 to September 2010, 958 women consented to repeat standard breast US supplemented by quantitative SW elastographic examination in this prospective multicenter institutional review board-approved, HIPAA-compliant protocol. B-mode Breast Imaging Reporting and Data System (BI-RADS) features and assessments were recorded. SW elastographic evaluation (mean, maximum, and minimum elasticity of stiffest portion of mass and surrounding tissue; lesion-to-fat elasticity ratio; ratio of SW elastographic-to-B-mode lesion diameter or area; SW elastographic lesion shape and homogeneity) was performed. Qualitative color SW elastographic stiffness was assessed independently. Nine hundred thirty-nine masses were analyzable; 102 BI-RADS category 2 masses were assumed to be benign; reference standard was available for 837 category 3 or higher lesions. Considering BI-RADS category 4a or higher as test positive for malignancy, effect of SW elastographic features on area under the receiver operating characteristic curve (AUC), sensitivity, and specificity after reclassifying category 3 and 4a masses was determined. RESULTS: Median participant age was 50 years; 289 of 939 (30.8%) masses were malignant (median mass size, 12 mm). B-mode BI-RADS AUC was 0.950; eight of 303 (2.6%) BI-RADS category 3 masses, 18 of 193 (9.3%) category 4a lesions, 41 of 97 (42%) category 4b lesions, 42 of 57 (74%) category 4c lesions, and 180 of 187 (96.3%) category 5 lesions were malignant. By using visual color stiffness to selectively upgrade category 3 and lack of stiffness to downgrade category 4a masses, specificity improved from 61.1% (397 of 650) to 78.5% (510 of 650) (P<.001); AUC increased to 0.962 (P=.005). Oval shape on SW elastographic images and quantitative maximum elasticity of 80 kPa (5.2 m/sec) or less improved specificity (69.4% [451 of 650] and 77.4% [503 of 650], P<.001 for both), without significant improvement in sensitivity or AUC. CONCLUSION: Adding SW elastographic features to BI-RADS feature analysis improved specificity of breast US mass assessment without loss of sensitivity.

Impact of the Quality assured Mamma Diagnostic (QuaMaDi) programme on survival of breast cancer patients.

OBJECTIVE: To evaluate the effect of the Quality assured Mamma Diagnostic programme (QuaMaDi) introduced in 2001 on breast cancer and mortality on a population basis. QuaMaDi provides a standardized diagnostic process for symptomatic or at risk women of all ages. The process includes independent double-reading of mammograms, additional ultrasound, and if suspicious an expert reading and assessment. We tested the hypothesis that QuaMaDi has influenced breast cancer epidemiology and survival positively. METHODS: The QuaMaDi cohort of breast cancer patients, diagnosed within the programme between 2001 and 2007, was linked to the cancer registry dataset of all breast cancer cases in Schleswig-Holstein, Germany. By this record-linkage procedure participants of QuaMaDi could be marked in the cancer registry data. Overall survival rates of 3096 patients diagnosed within QuaMaDi were compared to 5417 patients diagnosed outside QuaMaDi, matched by year of diagnosis, using multivariate Cox proportional hazard models. RESULTS: Crude hazard ratio for overall survival was HR 0.43 (95% CI 0.35-0.52) for breast cancer cases detected inside QuaMaDi versus those diagnosed outside the programme. After stepwise adjustment for age, grading, histology, treatment, and tumour stage, the survival advantage in QuaMaDi diagnosed breast cancer patients was still statistically significant (HR 0.78, 95% CI 0.64-0.96). CONCLUSION: Evidence is provided that the QuaMaDi programme has a beneficial impact on the first 5-year overall survival rate after breast cancer beyond a favourable tumour stage distribution. Thus, we conclude that QuaMaDi contributes to improved health care for women, who are not eligible for mammography screening.

Leiomyomatosis peritonealis disseminata in a pregnant woman.

BACKGROUND: Leiomyomatosis peritonealis disseminata (LPD) is a rare disease occurring as intraabdominal benign tumors. The underlying mechanism of LPD development in premenopausal females is still unknown, but high levels of estrogen and progesterone seem to play a major role. CASE: We present a case of a 29-year-old gravida 1, 22 6/7 weeks of gestation with symptoms of an acute abdomen. Abdominal ultrasound and MRI showed intraabdominal masses of uncertain origin most likely to be an extreme example of pseudomyxoma peritonei. Explorative laparotomy was performed, and histopathological analysis revealed benign tumors classified as leiomyomatosis. A cesarean section was performed due to increasing abdominal pain and excessive elevated inflammatory serum parameters. Postpartum, a spontaneous regression of the LPD was marked. CONCLUSION: LPD is a rare disease of young women. Excessive hormonal exposure seems to play a major role. Diagnosis is often difficult and a histopathological analysis is needed.

Articular cartilage mineralization in osteoarthritis of the hip.

BACKGROUND: The aim of this study was to examine the frequency of articular cartilage calcification in patients with end-stage hip OA. Further, its impact on the clinical situation and the OA severity are analyzed. METHODS: Eighty patients with OA of the hip who consecutively underwent total hip replacement were prospectively evaluated, and 10 controls were included. The patients' X-rays were analyzed for the presence of articular cartilage mineralization. A Harris Hip Score (HHS) was preoperatively calculated for every patient.Slab specimens from the femoral head of bone and cartilage and an additional square centimeter of articular cartilage from the main chondral defect were obtained from each patient for analysis of mineralization by digital contact radiography (DCR). Histological grading was also performed. In a subset of 20 patients, minerals were characterized with an electron microscope (FE-SEM). RESULTS: Calcifications were seen in all OA cartilage and slab specimens using DCR, while preoperative X-rays revealed calcification in only 17.5%. None of the control cartilage specimens showed mineralization. There was a highly significant inverse correlation between articular cartilage calcification and preoperative HHS. Histological OA grade correlated positively with the amount of matrix calcification. FE-SEM analysis revealed basic calcium phosphate (BCP) as the predominant mineral; CPPD crystals were found in only two patients. CONCLUSIONS: Articular cartilage calcification is a common event in osteoarthritis of the hip. The amount of calcification correlates with clinical symptoms and histological OA grade.

Laparoscopic mesh-augmented hiatoplasty as a method to treat gastroesophageal reflux without fundoplication: single-center experience with 306 consecutive patients.

BACKGROUND: Laparoscopic fundoplication represents the surgical standard treatment of gastroesophageal reflux disease. However, because of persisting side effects the method is not without controversy. Laparoscopic mesh-augmented hiatoplasty might be an alternative. METHODS: In 306 consecutive patients the perioperative course and symptomatic outcome was analyzed after a mean follow-up period of 52 months. RESULTS: The mean DeMeester symptom score decreased from 5.3 to 2.0 (P < .001). Acid-suppressive therapy on a regular basis was discontinued in 79% of patients. The gas bloating value decreased from .7 to .5 (P = .031), and the dysphagia value increased from .5 to .9 (P < .001). Belching and vomiting were possible in 93% and 88% of patients, respectively. Mesh-related complications with the need for reoperation occurred in 1% of patients. CONCLUSIONS: Laparoscopic mesh-augmented hiatoplasty is safe and does have an antireflux effect even without fundoplication. Side effects seem to be reasonable.

Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial.

OBJECTIVE: To evaluate the diagnostic efficacy (accuracy, sensitivity, specificity) of 1.0 M gadobutrol versus 0.5 M gadopentetate for the classification of lesions as either benign or malignant in patients with known or suspected liver lesions. METHODS AND MATERIALS: A multicenter, phase-III, randomized, interindividually controlled comparison study with blinded reader evaluation was performed to investigate the diagnostic efficacy of a bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentetate at a dose of 0.1 mmol Gd/kg BW. The imaging protocol included a dynamic 3D-evaluation, static conventional, and fat saturated T1-weighted sequences. MR datasets were evaluated by 3 independent radiologists. The standard of reference was defined by an independent truth panel (radiologist or hepatologist). The safety evaluation included adverse events, vital signs, and physical examination. RESULTS: A total of 497 of 572 patients were eligible for the final efficacy analysis. Noninferiority of gadobutrol-enhanced magnetic resonance imaging (MRI) for the classification of liver lesions was demonstrated on the basis of diagnostic accuracy determined by the on-site investigators (-0.098, 0.021) as well as for the average reader of the blinded evaluation (-0.096, 0.014) (95% confidence interval), compared with the predefined standard of reference. Very similar increases in sensitivity (ranging from approximately 10% to approximately 55%) and specificity (ranging from approximately 1% to approximately 18%) compared with precontrast MRI were also observed for the 2 contrast agent groups, with maximum differences of 4%.Very similar, low rates of adverse events were recorded for each of the 2 groups. No clinically relevant changes in vital signs or the results of the physical examination were observed in any patient. CONCLUSION: This study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol (0.1 mmol/kg body weight) to 0.5 M gadopentetate (0.1 mmol/kg body weight) in the diagnostic assessment of liver lesions with contrast-enhanced MRI. The known excellent safety profile of gadobutrol was confirmed in this clinical trial and is similar to that of gadopentetate.

Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial.

The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers ('average reader') was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.