Evaluation of the FUSION-X-US-II prototype to combine automated breast ultrasound and tomosynthesis.

OBJECTIVE: The FUSION-X-US-II prototype was developed to combine 3D automated breast ultrasound (ABUS) and digital breast tomosynthesis in a single device. We evaluated the performance of ABUS and tomosynthesis in a single examination in a clinical setting. METHODS: In this prospective feasibility study, digital breast tomosynthesis and ABUS were performed using the FUSION-X-US-II prototype without any change of the breast position in patients referred for clarification of breast lesions with an indication for tomosynthesis. The tomosynthesis and ABUS images of the prototype were interpreted independently from the clinical standard by a breast diagnostics specialist. Any detected lesion was classified using BI-RADS® scores, and results of the standard clinical routine workup (gold standard) were compared to the result of the separate evaluation of the prototype images. Image quality was rated subjectively and coverage of the breast was measured. RESULTS: One hundred one patients received both ABUS and tomosynthesis using the prototype. The duration of the additional ABUS acquisition was 40 to 60 s. Breast coverage by ABUS was approximately 80.0%. ABUS image quality was rated as diagnostically useful in 86 of 101 cases (85.1%). Thirty-three of 34 malignant breast lesions (97.1%) were identified using the prototype. CONCLUSION: The FUSION-X-US-II prototype allows a fast ABUS scan in combination with digital breast tomosynthesis in a single device integrated in the clinical workflow. Malignant breast lesions can be localized accurately with direct correlation of ABUS and tomosynthesis images. The FUSION system shows the potential to improve breast cancer screening in the future after further technical improvements. KEY POINTS: • The FUSION-X-US-II prototype allows the combination of automated breast ultrasound and digital breast tomosynthesis in a single device without decompression of the breast. • Image quality and coverage of ABUS are sufficient to accurately detect malignant breast lesions. • If tomosynthesis and ABUS should become part of breast cancer screening, the combination of both techniques in one device could offer practical and logistic advantages. To evaluate a potential benefit of a combination of ABUS and tomosynthesis in screening-like settings, further studies are needed.

First proof-of-concept evaluation of the FUSION-X-US-II prototype for the performance of automated breast ultrasound in healthy volunteers.

PURPOSE: The FUSION-X-US-II prototype was developed to combine 3D-automated breast ultrasound (ABUS) and digital breast tomosynthesis in a single device without decompressing the breast. We evaluated the technical function, feasibility of the examination workflow, image quality, breast tissue coverage and patient comfort of the ABUS device of the new prototype. METHODS: In this prospective feasibility study, the FUSION-X-US-II prototype was used to perform ABUS in 30 healthy volunteers without history of breast cancer. The ABUS images of the prototype were interpreted by a physician with specialization in breast diagnostics. Any detected lesions were measured and classified using BI-RADS® scores. Image quality was rated subjectively by the physician and coverage of the breast was measured. Patient comfort was evaluated by a questionnaire after the examination. RESULTS: One hundred and six scans were performed (61 × CC, 23 × ML, 22 × MLO) in 60 breasts. Image acquisition and processing by the prototype was fast and accurate. Breast coverage by ABUS was approximately 90.8%. Sixteen breast lesions (all benign, classified as BIRADS® 2) were identified. The examination was tolerated by all patients. CONCLUSION: The FUSION-X-US-II prototype allows a rapid ABUS scan with mostly high patient comfort. Technical developments resulted in an improvement of quality and coverage compared to previous prototype versions. The results are encouraging for a test of the prototype in a clinical setting in combination with tomosynthesis.

Initial results of the FUSION-X-US prototype combining 3D automated breast ultrasound and digital breast tomosynthesis.

PURPOSE: To determine the feasibility of a prototype device combining 3D-automated breast ultrasound (ABVS) and digital breast tomosynthesis in a single device to detect and characterize breast lesions. METHODS: In this prospective feasibility study, the FUSION-X-US prototype was used to perform digital breast tomosynthesis and ABVS in 23 patients with an indication for tomosynthesis based on current guidelines after clinical examination and standard imaging. The ABVS and tomosynthesis images of the prototype were interpreted separately by two blinded experts. The study compares the detection and BI-RADS® scores of breast lesions using only the tomosynthesis and ABVS data from the FUSION-X-US prototype to the results of the complete diagnostic workup. RESULTS: Image acquisition and processing by the prototype was fast and accurate, with some limitations in ultrasound coverage and image quality. In the diagnostic workup, 29 solid lesions (23 benign, including three cases with microcalcifications, and six malignant lesions) were identified. Using the prototype, all malignant lesions were detected and classified as malignant or suspicious by both investigators. CONCLUSION: Solid breast lesions can be localized accurately and fast by the Fusion-X-US system. Technical improvements of the ultrasound image quality and ultrasound coverage are needed to further study this new device. KEY POINTS: The prototype combines tomosynthesis and automated 3D-ultrasound (ABVS) in one device. It allows accurate detection of malignant lesions, directly correlating tomosynthesis and ABVS data. The diagnostic evaluation of the prototype-acquired data was interpreter-independent. The prototype provides a time-efficient and technically reliable diagnostic procedure. The combination of tomosynthesis and ABVS is a promising diagnostic approach.

Initial clinical results with a fusion prototype for mammography and three-dimensional ultrasound with a standard mammography system and a standard ultrasound probe.

BACKGROUND: Combinations *Equal contributors. of different imaging techniques in fusion devices appear to be associated with improvements in diagnostic assessment. PURPOSE: The aim of this study was to test the feasibility of using an automated standard three-dimensional (3D) ultrasound (US) device fused with standard mammography for the first time in breast cancer patients. MATERIAL AND METHODS: Digital mammograms and 3D automated US images were obtained in 23 patients with highly suspicious breast lesions. A recently developed fusion machine consisting of an ABVS 3D US transducer from an Acuson S2000 machine and a conventional Mammomat Inspiration device (both Siemens Healthcare GmbH, Erlangen, Germany) were used for the purpose. The feasibility of the examinations, imaging coverage, and patients' experience of the procedure were examined. RESULTS: In 15 out of 19 patients, the region of interest (ROI) with the tumor marked in the mammogram was visible on US. The examination was experienced positively by the patients, with no unexpected pain or injury. The examination was time-saving and well tolerated. CONCLUSION: In conclusion, we have shown initial clinical feasibility of an US/radiography fusion prototype with good localization and evaluation of the ROIs. The combined examination was well tolerated. The simultaneous evaluation with mammography and US imaging may be able to improve detection and reduce examiner-related variability.

Towards a biomechanical breast model to simulate and investigate breast compression and its effects in mammography and tomosynthesis.

Objective. In mammography, breast compression forms an essential part of the examination and is achieved by lowering a compression paddle on the breast. Compression force is mainly used as parameter to estimate the degree of compression. As the force does not consider variations of breast size or tissue composition, over- and undercompression are a frequent result. This causes a highly varying perception of discomfort or even pain in the case of overcompression during the procedure. To develop a holistic, patient specific workflow, as a first step, breast compression needs to be thoroughly understood. The aim is to develop a biomechanical finite element breast model that accurately replicates breast compression in mammography and tomosynthesis and allows in-depth investigation. The current work focuses thereby, as a first step, to replicate especially the correct breast thickness under compression.Approach. A dedicated method for acquiring ground truth data of uncompressed and compressed breasts within magnetic resonance (MR) imaging is introduced and transferred to the compression within x-ray mammography. Additionally, we created a simulation framework where individual breast models were generated based on MR images.Main results. By fitting the finite element model to the results of the ground truth images, a universal set of material parameters for fat and fibroglandular tissue could be determined. Overall, the breast models showed high agreement in compression thickness with a deviation of less than ten percent from the ground truth.Significance. The introduced breast models show a huge potential for a better understanding of the breast compression process.

Clinical prototype implementation enabling an improved day-to-day mammography compression.

PURPOSE: In mammography, breast compression is achieved by lowering a compression paddle on the breast. Despite the directive that compression is needed, there is no concrete guideline on its execution. To estimate the degree of compression, current mammography units only provide compression force and breast thickness as parameters. Therefore, radiographers could be induced to mainly determine the level of compression based on compression force and apply the same value to all breast sizes. In this case, smaller breast sizes are exposed to higher pressure. This results in a highly varying perception of discomfort or even pain during the procedure, depending on the breast size. METHODS: To overcome this imbalance, current research results suggest that pressure might be a more qualified parameter for a more uniform compression among all breast sizes. To utilize pressure, the contact area between breast and compression paddle must be determined. In this paper, we present an easy-to-implement prototype enabling a real-time pressure-based measure without the need of direct patient contact. Using an optical camera, the contact area between the breast and the compression paddle is automatically segmented by a deep learning model. RESULTS: The model provides a mean pixel accuracy of 96.7% (SD: 2.3%), mean frequency-weighted intersection over union of 88.5% (SD: 6.3%), and a Dice score of 93.6% (SD: 2.2%). The subsequent pressure display is updated more than five times per second which enables the use in clinical routines to set the compression level. CONCLUSION: This prototype could help guiding to an improved breast compression routine in mammography procedures.

Comprehensive Comparison of Image Quality Aspects Between Conventional and Plane-Wave Imaging Methods on a Commercial Scanner.

Coherent plane-wave compound imaging (CPWCI) is used as alternative for conventional focused imaging (CFI) to increase frame rates linearly with the ratio number of imaging lines to steering angles. In this study, the image quality was compared between CPWCI and CFI, and the effect of steering angles (range and number) and beamforming strategies was evaluated in CPWCI. In automated breast volume scanners (ABVSs), which suffer from reduced volume rates, CPWCI might be an excellent candidate to replace CFI. Therefore, the image quality of CFI currently in ABVS and CPWCI was also compared in an in vivo breast lesion. Images were obtained by a Siemens Sequoia ultrasound system, and two transducers (14L5 and 10L4) in a CIRS multipurpose phantom (040GSE) and a breast lesion. Phantom results showed that contrast sensitivity and resolution, axial resolution, and generalized contrast-to-noise ratio (gCNR; imaging depths <45 mm) were similar for most imaging sequences. CNR (imaging depths ≥45 mm), penetration, and lateral resolution were significantly improved for CPWCI (15 angles) compared to CFI for both transducers. In CPWCI, certain combinations of steering angles and beamforming methods yielded improved gCNR (small angles and delay-and-sum) or lateral resolution (large angles and Lu's-fk). Image quality seemed similar between CPWCI and CFI (three angles incoherent compounded as in ABVS) by visual inspection of the in vivo breast lesion images.

Acoustic radiation force contrast in MRI: detection of calcifications in tissue-mimicking phantoms.

PURPOSE: Mammography is a widely used tool for the screening of breast cancer, and calcifications are a common finding in most mammograms. The location, size, number, morphology, and distribution of calcifications are an important information to differentiate a benign lesion from probably malignant pathologies. Calcifications are not detectable with a standard dynamic contrast enhanced breast MRI. The authors present a novel method for the detection and imaging of calcifications in breast tissue without ionizing radiation or contrast agents. METHODS: Measurements of localized tissue displacement in phantoms due to applied acoustic radiation force were performed. This displacement was imaged with a displacement sensitive spin-echo MRI sequence. Pieces of eggshell that represent calcifications were embedded in tissue-mimicking agarose phantoms. The sizes of the calcifications were 0.8 x 0.8 x 0.4, 1.5 x 1.5 x 0.4, and 2 x 3 x 0.4 mm3. The calcifications were scanned with ultrasound (U.S.) at 2.5 MHz and intensities up to I(spta) =7.18 W/cm2. The U.S. beam was moved inside the phantom by a computer-controlled three-dimensional hydraulic positioning system. The U.S. beam was scanned over the two smaller calcifications with the displacement sensitivity of the MRI sequence parallel to the U.S. beam path. Grayscale coded maps of the displacement scans are presented. For the 0.8 x 0.8 x 0.4 mm3 calcification, the U.S. intensities were varied. Finite element simulations were performed to verify if the experiments complied with theory. RESULTS: The authors found that the displacement caused by the U.S. is increased at the position of the calcification. The area of increased displacement is at least twice as large as the calcification itself. The simulations show this increase in displacement and area at the position of the calcification. When changing the displacement sensitivity direction to perpendicular to the U.S. beam, a crossed black and white four-leaf clover is visible at the position of the calcification. CONCLUSIONS: The U.S. is scattered and reflected by the calcifications. This leads to the increased displacement which is transmitted to the surrounding material because of the elastic coupling between the calcification and the agarose material. Due to the high differences in acoustic impedance and elastic properties between the surrounding tissue and the calcification, even the detection of pieces smaller than the resolution of the MRI scanner is possible. The acoustic radiation force contrast in MR phase-difference images offers a positive signal for calcifications from a smooth background in phantoms. This method offers a possibility of differentiating qualitatively and quantitatively hard calcifications from stiffer inclusions such as tumors.

Assessment of the additional clinical potential of X-ray dark-field imaging for breast cancer in a preclinical setup.

BACKGROUND: Mammography can identify calcifications up to 50-100 µm in size as a surrogate parameter for breast cancer or ductal carcinoma in situ (DCIS). Microcalcifications measuring <50 µm are also associated with breast cancer or DCIS and are frequently not detected on mammography, although they can be detected with dark-field imaging. This study examined whether additional breast examination using X-ray dark-field imaging can increase the detection rate of calcifications. Advances in knowledge: (1) evaluation of additional modality of breast imaging; (2) specific evaluation of breast calcifications.Implications for patient care: the addition of X-ray dark-field imaging to conventional mammography could detect additional calcifications. METHODS: Talbot-Lau X-ray phase-contrast imaging and X-ray dark-field imaging were used to acquire images of breast specimens. The radiation dosage with the technique is comparable with conventional mammography. Three X-ray gratings with periods of 5-10 µm between the X-ray tube and the flat-panel detector provide three different images in a single sequence: the conventional attenuation image, differential phase image, and dark-field image. The images were read by radiologists. Radiological findings were marked and examined pathologically. The results were described in a descriptive manner. RESULTS: A total of 81 breast specimens were investigated with the two methods; 199 significant structures were processed pathologically, consisting of 123 benign and 76 malignant lesions (DCIS or invasive breast cancer). X-ray dark-field imaging identified 15 additional histologically confirmed carcinoma lesions that were visible but not declared suspicious on digital mammography alone. Another four malignant lesions that were not visible on mammography were exclusively detected with X-ray dark-field imaging. CONCLUSIONS: Adding X-ray dark-field imaging to digital mammography increases the detection rate for breast cancer and DCIS associated lesions with micrometer-sized calcifications.The use of X-ray dark-field imaging may be able to provide more accurate and detailed radiological classification of suspicious breast lesions.Adding X-ray dark-field imaging to mammography may be able to increase the detection rate and improve preoperative planning in deciding between mastectomy or breast-conserving therapy, particularly in patients with invasive lobular breast cancer.

Exploration of different x-ray Talbot-Lau setups for dark-field lung imaging examined in a porcine lung.

X-ray dark-field imaging is a promising technique for lung diagnosis. Due to the alveolar structure of lung tissue, a higher contrast is obtained by the dark-field image compared to the attenuation image. Animal studies indicate an enhancement regarding the detection of lung diseases in early stages. In this publication, we focus on the influence of different Talbot-Lau interferometer specifications while maintaining the x-ray source, sample magnification and detector system. By imaging the same porcine lung with three different grating sets, we analyze the contrast-to-noise ratio of the obtained dark-field images with respect to visibility and correlation length. We demonstrate that relatively large grating periods of the phase and of the analyzer grating are sufficient for high quality lung imaging at reasonable dose levels.

Single-shot Talbot-Lau x-ray dark-field imaging of a porcine lung applying the moiré imaging approach.

Talbot-Lau x-ray imaging provides additionally to the conventional attenuation image, two further images: the differential phase-contrast image which is especially sensitive to differences in refractive properties and the dark-field image which is showing the x-ray scattering properties of the object. Thus, in the dark-field image sub-pixeled object information can be observed. As it has been shown in recent studies, this is of special interest for lung imaging. Changes in the alveoli structure, which are in the size of one detector pixel, can be seen in the dark-field images. A fast acquisition process is crucial to avoid motion artifacts due to heartbeat and breathing of the patient. Using moiré imaging the images can be acquired with a single-shot exposure. Nevertheless, the spatial resolution is reduced compared to the phase-stepping acquisition. We evaluate the results of both imaging techniques towards their feasibility in clinical routine. Furthermore, we analyse the influence of artificial linear object movement on the image quality, in order to simulate the heartbeat of a patient.

Enhanced reconstruction algorithm for moiré artifact suppression in Talbot-Lau x-ray imaging.

Talbot-Lau x-ray imaging (TLXI) is an innovative and promising imaging technique providing information about the x-ray attenuation, scattering, and refraction features of objects. However, the method is susceptible to vibrations and system component imprecisions, which are inevitable in clinical and industrial practice. Those influences provoke grating displacements and hence errors in the acquired raw data, which cause moiré artifacts in the reconstructed images. We developed an enhanced reconstruction algorithm capable of compensating these errors by adjusting the grating positions and thus suppressing the occurrence of moiré artifacts. The algorithm has been developed with regard to a future application in medical practice. The capability of the algorithm is demonstrated on a medical data set of a human hand (post-mortem) acquired under clinical conditions using a pre-clinical TXLI prototype. It is shown that the algorithm reliably suppresses moiré artifacts, preserves image contrast, does not blur anatomical structures or prevent quantitative imaging, and is executable on low-dose data sets. In addition, the algorithm runs autonomously without the need of interaction or rework of the final results. In conclusion, the proposed reconstruction algorithm facilitates the use of TLXI in clinical practice and allows the exploitation of the method's full diagnostic potential in future medical applications.

Improved Detection of Foreign Bodies on Radiographs Using X-ray Dark-Field and Phase-Contrast Imaging.

PURPOSE: The aim of this study was to investigate whether the detection of foreign bodies can be improved using dark-field and phase-contrast radiography compared with conventional (transmission) radiographs. MATERIALS AND METHODS: Experiments were performed using ex vivo pig paws, which were prepared with differently sized foreign bodies of metal, wood, and glass (n = 10 each). Paws without foreign bodies served as controls (n = 30). All images were acquired using an experimental grating-based large object radiography system. Five blinded readers (second- to fourth-year radiology residents) were asked to assess the presence or absence of any foreign body. Sensitivity and specificity for the detection of metal, wood, glass, and any foreign body were calculated and compared using McNemar test and generalized linear mixed models. RESULTS: Sensitivity for the detection of metal foreign bodies was 100% for all readers and image combinations. The sensitivity for the detection of wooden foreign bodies increased from 2% for transmission images to 78% when dark-field images were added (P < 0.0001). For glass foreign bodies, sensitivity increased from 84% for transmission images to 96% when adding phase-contrast images (P = 0.041). Sensitivity for the detection of any foreign body was 91% when transmission, dark-field, and phase-contrast images were viewed simultaneously, compared with 62% for transmission images alone (P < 0.0001). Specificity was 99% to 100% across all readers and radiography modalities. CONCLUSIONS: Adding dark-field images substantially improves the detection of wooden foreign bodies compared with the analysis of conventional (transmission) radiographs alone. Detection of glass foreign bodies was moderately improved when adding phase-contrast images.

A Standard Mammography Unit - Standard 3D Ultrasound Probe Fusion Prototype: First Results.

AIM: The combination of different imaging modalities through the use of fusion devices promises significant diagnostic improvement for breast pathology. The aim of this study was to evaluate image quality and clinical feasibility of a prototype fusion device (fusion prototype) constructed from a standard tomosynthesis mammography unit and a standard 3D ultrasound probe using a new method of breast compression. MATERIALS AND METHODS: Imaging was performed on 5 mastectomy specimens from patients with confirmed DCIS or invasive carcinoma (BI-RADS ™ 6). For the preclinical fusion prototype an ABVS system ultrasound probe from an Acuson S2000 was integrated into a MAMMOMAT Inspiration (both Siemens Healthcare Ltd) and, with the aid of a newly developed compression plate, digital mammogram and automated 3D ultrasound images were obtained. RESULTS: The quality of digital mammogram images produced by the fusion prototype was comparable to those produced using conventional compression. The newly developed compression plate did not influence the applied x-ray dose. The method was not more labour intensive or time-consuming than conventional mammography. From the technical perspective, fusion of the two modalities was achievable. CONCLUSION: In this study, using only a few mastectomy specimens, the fusion of an automated 3D ultrasound machine with a standard mammography unit delivered images of comparable quality to conventional mammography. The device allows simultaneous ultrasound - the second important imaging modality in complementary breast diagnostics - without increasing examination time or requiring additional staff.

Grating-based darkfield imaging of human breast tissue.

Mastectomy specimens were investigated using a Talbot-Lau X-ray imaging set-up. Significant structures in the darkfield were observed, which revealed considerably higher contrast than those observed in digital mammography. Comparison with the histomorphometric image proofs that the darkfield signal correlates with a tumor region containing small calcification grains of 3 to 30µm size.

On a dark-field signal generated by micrometer-sized calcifications in phase-contrast mammography.

We show that a distribution of micrometer-sized calcifications in the human breast which are not visible in clinical x-ray mammography at diagnostic dose levels can produce a significant dark-field signal in a grating-based x-ray phase-contrast imaging setup with a tungsten anode x-ray tube operated at 40 kVp. A breast specimen with invasive ductal carcinoma was investigated immediately after surgery by Talbot-Lau x-ray interferometry with a design energy of 25 keV. The sample contained two tumors which were visible in ultrasound and contrast-agent enhanced MRI but invisible in clinical x-ray mammography, in specimen radiography and in the attenuation images obtained with the Talbot-Lau interferometer. One of the tumors produced significant dark-field contrast with an exposure of 0.85 mGy air-kerma. Staining of histological slices revealed sparsely distributed grains of calcium phosphate with sizes varying between 1 and 40 µm in the region of this tumor. By combining the histological investigations with an x-ray wave-field simulation we demonstrate that a corresponding distribution of grains of calcium phosphate in the form of hydroxylapatite has the ability to produce a dark-field signal which would-to a substantial degree-explain the measured dark-field image. Thus we have found the appearance of new information (compared to attenuation and differential phase images) in the dark-field image. The second tumor in the same sample did not contain a significant fraction of these very fine calcification grains and was invisible in the dark-field image. We conclude that some tumors which are invisible in x-ray absorption mammography might be detected in the x-ray dark-field image at tolerable dose levels.