RESUMEN
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.
Asunto(s)
Mamografía , Ultrasonografía Mamaria , Femenino , Humanos , Mamografía/métodosRESUMEN
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.
Asunto(s)
Neoplasias de la Mama , Medicina , Femenino , Humanos , Ultrasonografía Mamaria/métodos , Mamografía/métodos , Neoplasias de la Mama/diagnóstico por imagenRESUMEN
The beginning of the 21st century has seen immense improvements in the quality of diagnosis and treatment of breast cancer due to several, simultaneous developments. In particular, the introduction of a certification program from the German Cancer Society based on level III guidelines has enhanced the transparency and quality of treatment of breast diseases for all actors. As a result, patients have benefited from intensified cooperation especially between core disciplines in breast disease, gynecology, pathology, and radiology. The standardized and synoptic reading of multiple diagnostic modalities has enabled precise sampling of histologic specimen, which has improved prognosis and the successful individualization of therapy. In this article the benefits of breast cancer diagnosis and therapy in a certified breast center are illustrated using four case examples.
Asunto(s)
Neoplasias de la Mama , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/terapia , Instituciones Oncológicas , Certificación , Femenino , Alemania , HumanosRESUMEN
EUSOBI and 30 national breast radiology bodies support mammography for population-based screening, demonstrated to reduce breast cancer (BC) mortality and treatment impact. According to the International Agency for Research on Cancer, the reduction in mortality is 40 % for women aged 50-69 years taking up the invitation while the probability of false-positive needle biopsy is <1 % per round and overdiagnosis is only 1-10 % for a 20-year screening. Mortality reduction was also observed for the age groups 40-49 years and 70-74 years, although with "limited evidence". Thus, we firstly recommend biennial screening mammography for average-risk women aged 50-69 years; extension up to 73 or 75 years, biennially, is a second priority, from 40-45 to 49 years, annually, a third priority. Screening with thermography or other optical tools as alternatives to mammography is discouraged. Preference should be given to population screening programmes on a territorial basis, with double reading. Adoption of digital mammography (not film-screen or phosphor-plate computer radiography) is a priority, which also improves sensitivity in dense breasts. Radiologists qualified as screening readers should be involved in programmes. Digital breast tomosynthesis is also set to become "routine mammography" in the screening setting in the next future. Dedicated pathways for high-risk women offering breast MRI according to national or international guidelines and recommendations are encouraged. KEY POINTS: ⢠EUSOBI and 30 national breast radiology bodies support screening mammography. ⢠A first priority is double-reading biennial mammography for women aged 50-69 years. ⢠Extension to 73-75 and from 40-45 to 49 years is also encouraged. ⢠Digital mammography (not film-screen or computer radiography) should be used. ⢠DBT is set to become "routine mammography" in the screening setting in the next future.
Asunto(s)
Neoplasias de la Mama/diagnóstico por imagen , Detección Precoz del Cáncer/métodos , Mamografía/métodos , Tamizaje Masivo/organización & administración , Adulto , Anciano , Neoplasias de la Mama/prevención & control , Europa (Continente) , Femenino , Humanos , Persona de Mediana Edad , Medio OrienteRESUMEN
Introduction: The presence of axillary lymph node involvement is an important prognostic factor and has a major impact on treatment decisions in early breast cancer patients. This study aimed to determine the role of cortical thickness in axillary ultrasound (AUS) as an indicator of lymph node metastasis. Methods: 766 patients with primary breast cancer who received AUS during clinical work-up were selected for this retrospective study. Lymph nodes were defined as suspicious if they showed a cortical thickness of >3.0 mm at 11-15 MHz harmonic imaging ultrasound. Lymph node involvement was assessed by core needle biopsy (n = 150), sentinel node dissection or axillary dissection. Extensive axillary spread (EAS) was diagnosed if more than two lymph nodes showed metastatic disease in histology. Results: AUS for detecting all lymph node metastases had a sensitivity of 62.27%, a specificity of 93.15% and a negative predictive value of 81.74%. However, the resulting negative predictive value for transcapsular growth was 93.97%, and for EAS 97.52%. Conclusion: EAS - in contrast to non-palpable involvement of 1 or 2 lymph nodes - contributes relevantly to the individualization of breast cancer treatment. In combination with SNB, AUS using cortical thickness as the main distinctive parameter seems to be an easily available, robust tool of diagnosing extensive axillary metastases. If AUS proves negative, it helps to reduce the number of classic axillary dissections.
RESUMEN
PURPOSE: The aim of this study was to evaluate the feasibility and the accuracy of a secondary, metachronous ultrasound (US)-guided marking of the stereotactic vacuum-assisted breast biopsy (ST-VABB) area. MATERIALS AND METHODS: The institutional ethics committee approved the study. The retrospective study included 98 patients. In ST-VABB of 45 women, no tissue markers were deployed at the biopsy site, even if no residual calcifications remained. After histology proved the necessity for a subsequent operation, the biopsy site was marked under US guidance using a coil marker. All interventions were technically successful. No complications occurred. Mammography was done to visualize the coil deployment. The distances from the center of the lesion and the biopsy cavity to the coil location were measured in both planes to evaluate the accuracy of the marking procedure. RESULTS: In 24 of the 46 cases, the whole lesion was biopsied without residual elements. The mean time between ST-VABB and sonographic marking of the lesion was 9.7 days (median 6.5). The biopsy cavity could be detected in 40 (87%) cases and thus marked exactly. The mean time of US-guided marking was 12.5 min. The mean distance between the coil and the target lesion was 0.6 ± 1.5 cm in the craniocaudal (cc) view and 0.5 ± 1.5 cm in the mediolateral (ml) view for all markings. The mean delta value from the distance nipple-original lesion and from the distance nipple-coil was 0.85 ± 1.2 cm (median 0.5) in the cc view and 0.88 ± 1.2 cm (median 0.6) in the ml view for all cases. Clip migration was not observed. CONCLUSION: Our study demonstrates the feasibility and the technical success of secondary metachronous coil marking of the biopsy site under US guidance after receipt of histology. This approach seems to be a cost-effective alternative to the standard procedure of the primary coil marking especially in all completely removed lesions. It may offer advantages for allergic patients.
RESUMEN
Organizers of medical educational courses are often confronted with questions that are clinically relevant yet trespassing the frontiers of scientifically proven, evidence-based medicine at the point of care. Therefore, since 2007 organizers of breast teaching courses in German language met biannually to find a consensus in clinically relevant questions that have not been definitely answered by science. The questions were prepared during the 3 months before the meeting according to a structured process and finally agreed upon the day before the consensus meeting. At the consensus meeting, the open questions concerning 2D/3D mammography, breast ultrasound, MR mammography, interventions as well as risk-based imaging of the breast were presented first for electronic anonymized voting, and then the results of the audience were separately displayed from the expert votes. Thereafter, an introductory statement of the moderator was followed by pros/cons of two experts, and subsequently the final voting was performed. With ≥75% of votes of the expert panel, an answer qualified as a consensus statement. Seventeen consensus statements were gained, addressing for instance the use of 2D/3D mammography, breast ultrasound in screening, MR mammography in women with intermediate breast cancer risk, markers for localization of pathologic axillary lymph nodes, and standards in risk-based imaging of the breast. After the evaluation, comments from the experts on each field were gathered supplementarily. Methodology, transparency, and soundness of statements achieve a unique yield for all course organizers and provide solid pathways for decision making in breast imaging.
RESUMEN
Every year the Breast Committee of the Arbeitsgemeinschaft Gynäkologische Onkologie (German Gynecological Oncology Group, AGO), a group of gynecological oncologists specialized in breast cancer and interdisciplinary members specialized in pathology, radiologic diagnostics, medical oncology, and radiation oncology, prepares and updates evidence-based recommendations for the diagnosis and treatment of patients with early and metastatic breast cancer. Every update is performed according to a documented rule-fixed algorithm, by thoroughly reviewing and scoring the recent publications for their scientific validity and clinical relevance. This current publication presents the 2019 update on the recommendations for metastatic breast cancer.
RESUMEN
BACKGROUND: The management of intraductal papilloma without atypia (IDP) in breast needle biopsy remains controversial. This study investigates the upgrade rate of IDP to carcinoma and clinical and radiologic features predictive of an upgrade. METHODS: Patients with a diagnosis of IDP on image-guided (mammography, ultrasound, magnetic resonance imaging) core needle or vacuum-assisted biopsy and surgical excision of this lesion at a certified breast center between 2007 and 2017 were included in this institutional review board-approved retrospective study. Appropriate statistical tests were performed to assess clinical and radiologic characteristics associated with an upgrade to malignancy at excision. RESULTS: For 60 women with 62 surgically removed IDPs, the upgrade rate to malignancy was 16.1% (10 upgrades, 4 invasive ductal carcinoma, 6 ductal carcinoma in situ). IDPs with upgrade to carcinoma showed a significantly greater distance to the nipple (63.5 vs. 36.8 mm; p = 0.012). No significant associations were found between upgrade to carcinoma and age, menopausal status, lesion size, microcalcifications, BI-RADS descriptors, initial BI-RADS category, and biopsy modality. CONCLUSION: The upgrade rate at excision for IDPs diagnosed with needle biopsy was higher than expected according to some guideline recommendations. Observation only might not be appropriate for all patients with IDP, particularly for those with peripheral IDP.
RESUMEN
Purpose The aim of this official guideline coordinated and published by the German Society for Gynecology and Obstetrics (DGGG) and the German Cancer Society (DKG) was to optimize the screening, diagnosis, therapy and follow-up care of breast cancer. Methods The process of updating the S3 guideline dating from 2012 was based on the adaptation of identified source guidelines which were combined with reviews of evidence compiled using PICO (Patients/Interventions/Control/Outcome) questions and the results of a systematic search of literature databases and the selection and evaluation of the identified literature. The interdisciplinary working groups took the identified materials as their starting point to develop recommendations and statements which were modified and graded in a structured consensus procedure. Recommendations Part 1 of this short version of the guideline presents recommendations for the screening, diagnosis and follow-up care of breast cancer. The importance of mammography for screening is confirmed in this updated version of the guideline and forms the basis for all screening. In addition to the conventional methods used to diagnose breast cancer, computed tomography (CT) is recommended for staging in women with a higher risk of recurrence. The follow-up concept includes suggested intervals between physical, ultrasound and mammography examinations, additional high-tech diagnostic procedures, and the determination of tumor markers for the evaluation of metastatic disease.
RESUMEN
Purpose The aim of this official guideline coordinated and published by the German Society for Gynecology and Obstetrics (DGGG) and the German Cancer Society (DKG) was to optimize the screening, diagnosis, therapy and follow-up care of breast cancer. Method The process of updating the S3 guideline published in 2012 was based on the adaptation of identified source guidelines. They were combined with reviews of evidence compiled using PICO (Patients/Interventions/Control/Outcome) questions and with the results of a systematic search of literature databases followed by the selection and evaluation of the identified literature. The interdisciplinary working groups took the identified materials as their starting point and used them to develop suggestions for recommendations and statements, which were then modified and graded in a structured consensus process procedure. Recommendations Part 2 of this short version of the guideline presents recommendations for the therapy of primary, recurrent and metastatic breast cancer. Loco-regional therapies are de-escalated in the current guideline. In addition to reducing the safety margins for surgical procedures, the guideline also recommends reducing the radicality of axillary surgery. The choice and extent of systemic therapy depends on the respective tumor biology. New substances are becoming available, particularly to treat metastatic breast cancer.
RESUMEN
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.
Asunto(s)
Neoplasias de la Mama/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Mamografía/métodos , Sarcoma/diagnóstico por imagen , Ultrasonografía Mamaria/métodos , Adulto , Anciano , Anciano de 80 o más Años , Mama/diagnóstico por imagen , Mama/patología , Neoplasias de la Mama/patología , Diagnóstico Diferencial , Femenino , Humanos , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
OBJECTIVE: The purpose of this retrospective analysis was to evaluate the likelihood of malignancy in prospectively categorized BI-RADS 4 and BI-RADS 5 calcifications. MATERIAL AND METHODS: This analysis included 849 women who underwent vacuum biopsy for BI-RADS 4 (with the subgroups 4A, 4B and 4C) or BI-RADS 5 calcifications between February 2007 and May 2015. Calcifications were classified according to the morphology and distribution descriptors of the BI-RADS lexicon (BI-RADS 4th edition lexicon). A standardized scheme (matrix) was used to combine the characteristics of the grouped calcifications with the BI-RADS assessment category. RESULTS: Overall, 275/849 (32%) lesions were found to be malignant. 285/327/208/29 calcified lesions were prospectively classified as BI-RADS 4A/4B/4C/5 indicating a risk for malignancy of 16%/27%/55%/90%, respectively. The morphology descriptors predicted the risk for malignancy as follows: typically benign (n=55): 2%; indeterminate (n=676): 27%; typically malignant (n=118): 80%. The distribution descriptors correlated with a malignant histology as follows: diffuse (n=0); round or oval (n=261): 22%; regional (n=398): 33%; segmental (n=106): 42%; linear or branching (n=85): 55%. There was a significant difference between the descriptor categories (p<0.0001). CONCLUSION: A standard scheme combining the morphology and distribution characteristics proved to be a helpful tool in diagnosis of calcifications, bridging the gap between description and classification of these lesions.
Asunto(s)
Neoplasias de la Mama/patología , Mama/patología , Calcinosis/patología , Adulto , Anciano , Biopsia con Aguja/métodos , Femenino , Humanos , Biopsia Guiada por Imagen , Mamografía/métodos , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , VacioRESUMEN
OBJECTIVES: We sought to compare signal changes using Ferucarbotran and gadobenate dimeglumine (Gd-BOPTA) in dynamic 3D T1-weighted (T1w) GRE imaging of the liver. MATERIAL AND METHODS: Thirty patients were prospectively included in the study. All patients underwent 2 high-field magnetic resonance (MR) examinations: first with Gd-BOPTA (Gd) and then after a mean interval of 4 days with ferucarbotran (Feru). Dynamic MRI was obtained with a 3D T1w GRE sequence (TR 6.33, TE 2.31, flip angle 20 degrees ). Contrast enhanced scans were assessed before intravenous injection of the contrast agent (precontrast), and postcontrast during the arterial phase (30 seconds), portal venous phase (60 seconds), and equilibrium phase (120 seconds). The signal intensities (SIs) of liver, spleen, aorta, and portal vein were defined by region of interest measurements. Signal intensity changes (SICs) and percentage signal intensity change (PSIC) were calculated using the formulas SIC=(SI pre - SI post)/SI pre and PSIC=SIC x 100%. RESULTS: Positive signal enhancement was observed after intravenous injection of Feru during all dynamic measurements, whereas the mean SI values were lower compared with Gd. During the portal venous phase the mean SI of Gd was up to a factor of 2.1 higher (portal vein). The widest difference of SIC was observed during the equilibrium phase for liver parenchyma (Gd, 1.03; Feru, 0.24). The dynamic signal courses were similar for liver, portal vein and aorta. Different signal courses were obtained for the spleen. CONCLUSIONS: Feru-enhanced T1w dynamic images demonstrated significant signal increases for liver, vessels, and spleen but overall lower signal intensities than Gd-BOPTA. The dynamic signal courses of ferucarbotran were similar to that of Gd-BOPTA during ll perfusion phases except in the spleen. Thus, it may be possible to detect typical enhancement pattern of focal liver lesions with Feru-enhanced dynamic T1w MRI.
Asunto(s)
Medios de Contraste , Imagenología Tridimensional , Hierro , Hepatopatías/diagnóstico , Imagen por Resonancia Magnética/métodos , Meglumina/análogos & derivados , Compuestos Organometálicos , Óxidos , Adulto , Anciano , Medios de Contraste/farmacocinética , Dextranos , Femenino , Óxido Ferrosoférrico , Humanos , Hierro/farmacocinética , Nanopartículas de Magnetita , Masculino , Meglumina/farmacocinética , Persona de Mediana Edad , Compuestos Organometálicos/farmacocinética , Óxidos/farmacocinética , Estudios Prospectivos , Sensibilidad y EspecificidadRESUMEN
OBJECTIVES: The objectives of this study were to assess practicability, outcome, and possible advantages of magnetic resonance imaging (MRI)-guided localizations with modified embolization coils for exclusively MRI-detected suspicious breast lesions. MATERIALS AND METHODS: We performed 131 MRI-guided preoperative localizations in 105 patients with exclusively MRI-detected breast lesions. Contrast-enhanced, T1-weighted, 3-dimensional gradient echo sequences were used for imaging. Breast fixation and needle guidance were achieved by a perforated plate. Lesion localization was performed with a modified embolization coil. The distance between coil and lesion was measured. Results of specimen radiography and histopathology were analyzed. RESULTS: Thirty-four of 131 lesions (26%) were malignant. Lesion localization and excision was successful in all patients. The mean distance between the coil and the lesion was 0.5 mm (+/-1.7 mm standard deviation). CONCLUSIONS: Exact MRI-guided preoperative localization of exclusively MRI-detected breast lesions by using a modified embolization coil is feasible with excellent precision. Advantages over wire localization procedures are the possibility of specimen x-ray and the independence from time and place of operation.
Asunto(s)
Neoplasias de la Mama/diagnóstico , Imagen por Resonancia Magnética/instrumentación , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/cirugía , Medios de Contraste , Embolización Terapéutica/instrumentación , Femenino , Humanos , Aumento de la Imagen , Persona de Mediana EdadRESUMEN
RATIONALE AND OBJECTIVE: To evaluate the potential of targeted electrical impedance scanning (EIS) for classifying suspicious breast lesions. METHODS: EIS was performed in full knowledge of mammographic findings and findings of clinical breast examination. One hundred seventeen patients with a total of 129 breast lesions were examined with EIS before breast biopsy (surgical excision or vacuum core biopsy). Diagnostic indexes of targeted EIS were calculated depending on major lesion characteristics. Capacitance and conductivity of all positive spots (S) and the surrounding normal breast tissue (NBT) were quantified using ROI measurements. The ratio S/NBT was calculated to compare true positive (n = 44) and false positive (n = 18) spots. RESULTS: With respect to histology, of the 129 lesions 71 were malignant and 58 lesions were benign. Overall sensitivity of targeted EIS was 62%, specificity 69%, PPV 71%, and NPV 60%. Sensitivity of EIS varied depending on the tumor size, which was between 48% (> 20 mm) and 71% (11-20 mm). Highest specificity (86%) was observed for large lesions (> 20 mm); however, the NPV was only 35% for lesions of that size. NPV was higher for nonpalpable lesions (74%) and clusters of microcalcifications (85.7%) compared with palpable lesions (39%) and solid lesions (44%). There was no statistical difference of S/NBT ratio neither for conductivity nor capacitance of true and false positive spots. Compared with true positive spots a trend of a higher conductivity ratio at 100 Hz and 200 Hz was seen for false positive spots. CONCLUSION: EIS showed mediocre overall diagnostic accuracy for classifying suspicious breast lesions. Quantitative analysis of positive EIS findings did not help to differentiate between false and true positive spots.
Asunto(s)
Neoplasias de la Mama/diagnóstico , Impedancia Eléctrica , Biopsia , Mama/patología , Reacciones Falso Positivas , Femenino , Humanos , Mamografía , Persona de Mediana Edad , Sensibilidad y EspecificidadRESUMEN
OBJECTIVE: The aim of our study was to differentiate benign from malignant breast lesions that had been detected exclusively on MR imaging by analyzing qualitative and quantitative lesion characteristics. MATERIALS AND METHODS: We performed 51 MR imaging-guided breast interventions (41 preoperative lesion localizations and 10 large-core needle biopsies) in 45 patients with exclusively MR imaging-detected lesions. All patients had previously undergone diagnostic dynamic contrast-enhanced MR imaging of the breast with a double breast coil at 1.0 T (n = 36) or 1.5 T (n = 15). The diagnostic MR images were evaluated on a workstation. Lesion morphology (size, shape, margin type, enhancement pattern), signal intensity parameters (time to peak enhancement, maximum slope of enhancement curve, washout, relative water content), and scores analogous to the Breast Imaging Reporting and Data System (BI-RADS) categories were correlated with histology. RESULTS: Histology revealed malignancy in 37.3% (19/51) of the lesions. The positive predictive value for malignancy of exclusively MR imaging-detectable lesions increased as the analogous BI-RADS category increased. Late inhomogeneous contrast enhancement was the only morphologic criterion that was statistically significantly correlated with malignancy. Malignant and benign lesions did not differ significantly in any of the quantitatively evaluated signal intensity parameters. Carcinomas showed a tendency toward faster and stronger enhancement and stronger washout. CONCLUSION: The classification of exclusively MR imaging-detectable breast lesions according to a combination of morphologic and perfusion parameters including the late enhancement pattern helps identify the lesions for which interventional MR imaging is required. Quantitative signal intensity data alone do not suffice.
Asunto(s)
Neoplasias de la Mama/patología , Imagen por Resonancia Magnética , Adulto , Anciano , Humanos , Persona de Mediana EdadRESUMEN
OBJECTIVE: The purpose of this study was to evaluate the clinical efficacy and dose response relationship of three doses of gadobenate dimeglumine for MRI of the breast and to compare the results with those obtained after a dose of 0.1 mmol/kg of body weight of gadopentetate dimeglumine. SUBJECTS AND METHODS. Gadobenate dimeglumine at 0.05, 0.1, or 0.2 mmol/kg of body weight or gadopentetate dimeglumine at 0.1 mmol/kg of body weight was administered by IV bolus injection to 189 patients with known or suspected breast cancer. Coronal three-dimensional T1-weighted gradient-echo images were acquired before and at 0, 2, 4, 6, and 8 min after the administration of the dose. Images were evaluated for lesion presence, location, size, morphology, enhancement pattern, conspicuity, and type. Lesion signal intensity-time curves were acquired, and lesion matching with on-site final diagnosis was performed. A determination of global lesion detection from unenhanced to contrast-enhanced and combined images was performed, and evaluations were made of the diagnostic accuracy for lesion detection and characterization. A full safety evaluation was conducted. RESULTS: Significant dose-related increases in global lesion detection were noted for patients who received gadobenate dimeglumine (p < 0.04, all evaluations). The sensitivity for detection was comparable for 0.1 and 0.2 mmol/kg of gadobenate dimeglumine, and specificity was highest with the 0.1 mmol/kg dose. Higher detection scores and higher sensitivity values for lesion characterization were found for 0.1 mmol/kg of gadobenate dimeglumine compared with 0.1 mmol/kg of gadopentetate dimeglumine, although more variable specificity values were obtained. No differences in safety were observed, and no serious adverse events were reported. CONCLUSION: Gadobenate dimeglumine is a capable diagnostic agent for MRI of the breast. Although preliminary, our results suggest that 0.1 mmol/kg of gadobenate dimeglumine may offer advantages over doses of 0.05 and 0.2 mmol/kg of gadobenate dimeglumine and 0.1 mmol/kg of gadopentetate dimeglumine for breast lesion detection and characterization.