Search

Objective: This follow-up study of BreastScreen Victoria’s pilot trial of digital breast tomosynthesis aimed to report interval cancer rates, screening sensitivity, and density-stratified outcomes for tomosynthesis vs mammography screening. Methods: Prospective pilot trial [ACTRN-12617000947303] in Maroondah BreastScreen recruited females ≥ 40 years presenting for screening (August 2017–November 2018) to DBT; concurrent screening participants who received mammography formed a comparison group. Follow-up of 24 months from screen date was used to ascertain interval cancers; automated breast density was measured. Results: There were 48 screen-detected and 9 interval cancers amongst 4908 tomosynthesis screens, and 34 screen-detected and 16 interval cancers amongst 5153 mammography screens. Interval cancer rate was 1.8/1000 (95%CI 0.8–3.5) for tomosynthesis vs 3.1/1000 (95%CI 1.8–5.0) for mammography (p = 0.20). Sensitivity of tomosynthesis (86.0%; 95% CI 74.2–93.7) was significantly higher than mammography (68.0%; 95% CI 53.3–80.5), p = 0.03. Cancer detection rate (CDR) of 9.8/1000 (95%CI 7.2–12.9) for tomosynthesis was higher than that of 6.6/1000 (95%CI 4.6–9.2) for mammography (p = 0.08); density-stratified analyses showed CDR was significantly higher for tomosynthesis than mammography (10.6/1000 vs 3.5/1000, p = 0.03) in high-density screens. Recall rate for tomosynthesis was significantly higher than for mammography (4.2% vs 3.0%, p < 0.001), and this increase in recall for tomosynthesis was evident only in high-density screens (5.6% vs 2.9%, p < 0.001). Conclusion: Although interval cancer rates did not significantly differ between screened groups, sensitivity was significantly higher for tomosynthesis than mammography screening. Advances in knowledge: In a program-embedded pilot trial, both increased cancer detection and recall rates from tomosynthesis were predominantly observed in high-density screens.

BACKGROUND Alcohol consumption is a major modifiable risk factor for female breast cancer, even in small amounts. However, awareness of this risk remains low. National breast screening programs are uniquely positioned to provide timely and targeted health information and behavior change strategies to improve alcohol literacy and reduce consumption. A breast screening service is a novel health care setting for brief alcohol intervention, with the potential for extensive reach. OBJECTIVE This study aimed to conduct a formative evaluation with breast screening service consumers to understand the need for, and acceptability of, brief alcohol intervention in the breast screening setting and collaboratively design a brief alcohol intervention (Health4Her); to test the effectiveness of Health4Her in improving knowledge of alcohol as a breast cancer risk factor (primary outcome), improving alcohol literacy, and reducing consumption among women attending a breast screening service; and to examine the implementation strategy through process evaluation. METHODS This was a hybrid type II effectiveness-implementation trial comprising a randomized controlled trial (RCT) alongside a mixed methods program evaluation guided by applicable elements of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and Consolidated Framework for Implementation Research. Formative evaluation comprised a retrospective analysis of alcohol consumption data (n=49,240), a web-based survey (n=391), and focus groups and interviews (n=31) with breast screening service consumers. Women attending routine mammography, drinking at any level, were recruited to the single-site, double-blind RCT (n=558), and completed a baseline assessment before randomization (1:1) to receive Health4Her (alcohol brief intervention + lifestyle information) or control (lifestyle information) via animation on an iPad. Follow-up assessments were performed 4 and 12 weeks after randomization. The process evaluation included evaluation of trial administrative data, participant quantitative (n=497) and qualitative feedback (n=30), and site staff qualitative feedback (n=11). RESULTS This research was funded in March and May 2019. Data collection for the formative evaluation and trial recruitment occurred between January and April 2020 and February and August 2021, respectively, with finalization of follow-up data collection in December 2021. Quantitative process evaluation data were collected during trial implementation, and collection of participant and staff feedback was finalized in December 2021. Results of the retrospective analysis of alcohol consumption data from breast screening service consumers is anticipated to be published in March 2023 and the results of the RCT to be published in March 2023. CONCLUSIONS This study is anticipated to generate new substantial knowledge on the alcohol consumption and literacy needs of women attending breast screening and the extent to which these can be addressed using a novel, tailored brief alcohol intervention. The study design permits the evaluation of the effectiveness and implementation of Health4Her to predict and facilitate uptake in breast screening services. CLINICALTRIAL ClinicalTrials.gov NCT04715516; https://clinicaltrials.gov/ct2/show/NCT04715516 INTERNATIONAL REGISTERED REPORT RR1-10.2196/44867

Rationale and Objectives Propagation-based phase-contrast CT (PB-CT) is an advanced X-ray imaging technology that exploits both refraction and absorption of the transmitted X-ray beam. This study was aimed at optimizing the experimental conditions of PB-CT for breast cancer imaging and examined its performance relative to conventional absorption-based CT (AB-CT) in terms of image quality and radiation dose. Materials and Methods Surgically excised breast mastectomy specimens (n = 12) were scanned using both PB-CT and AB-CT techniques under varying imaging conditions. To evaluate the radiological image quality, visual grading characteristics (VGC) analysis was used in which 11 breast specialist radiologists compared the overall image quality of PB-CT images with respect to the corresponding AB-CT images. The area under the VGC curve was calculated to measure the differences between PB-CT and AB-CT images. Results The highest radiological quality was obtained for PB-CT images using a 32 keV energy X-ray beam and by applying the Homogeneous Transport of Intensity Equation phase retrieval with the value of its parameter γ set to one-half of the theoretically optimal value for the given materials. Using these optimized conditions, the image quality of PB-CT images obtained at 4 mGy and 2 mGy mean glandular dose was significantly higher than AB-CT images at 4 mGy (AUCVGC = 0.901, p = 0.001 and AUCVGC = 0.819, p = 0.011, respectively). Conclusion PB-CT achieves a higher radiological image quality compared to AB-CT even at a considerably lower mean glandular dose. Successful translation of the PB-CT technique for breast cancer imaging can potentially result in improved breast cancer diagnosis.

Objectives To determine the total annual screening and further-investigation costs of investigating false-positive and true-positive mammograms in the Australian population breast-screening program. Methods This economic analysis used aggregate-level retrospective cohort data of women screened at a breast-screening clinic. Counts and frequencies of each diagnostic workup-sequence recorded were scaled up to national figures and costed by estimating per-patient costs of procedures using screening clinic cost data. Main outcomes and measures estimated were percentage share of total annual screening and further-investigation costs for the Australian population breast-screening program of investigating false-positive and true-positive mammograms. Secondary outcomes determined were average costs of investigating each false-positive and true-positive mammogram. Sensitivity analyses involved recalculating results excluding subgroups of patients below and above the screening age range of 50–74 years. Results Of 8235 patients, the median age was 60.35 years with interquartile range of 54.17–67.17 years. A total of 15.4% (ranging from 13.4 to 15.4% under different scenarios) of total annual screening and further-investigation costs were from investigating false-positive mammograms. This exceeded the share of costs from investigating true-positives (13%). Conclusions We have developed a transparent and non-onerous approach for estimating the costs of false-positive and true-positive mammograms associated with the national breast-screening program. While determining an optimal balance between false-positives and true-positive rates must rely primarily on health outcomes, costs are an important consideration. We recommend that future research adopts and refines similar approaches to facilitate better monitoring of these costs, benchmark against estimates from other screening programs, and support optimal policy development.

Introduction Australia's first population-based pilot trial comparing digital breast tomosynthesis (DBT) and digital mammography (DM) screening reported detection measures in 2019. This study describes the trial's secondary outcomes pertaining to the assessment process in women screened with DBT or DM, including the type of recalled abnormalities and the procedures performed. Methods Women with suspected abnormalities at screening were recalled for further investigation. Outcome measures were number of lesions assessed, types of imaging findings recalled to assessment, and data on testing and assessment outcomes; these were reported using descriptive analyses of lesion-specific data. Results A total of 274 lesions and 203 lesions were reported in the DBT-screened and DM-screened groups, respectively. There were a higher proportion of lesions depicted as calcifications (32.4% vs 21.3%), and a lower proportion of lesions depicted as asymmetrical densities (3.2% vs 15.7%) for DBT recalls than DM recalls. A lower proportion of DBT-recalled lesions was assessed with additional mammography than DM-recalled lesions (49.3% vs 93.1%). Higher proportions of DBT-recalled lesions than DM-recalled lesions were investigated with clinical breast examination (50.4% vs 39.9%), core needle biopsy (45.6% vs 28.6%) and open biopsy (4.0% vs 1.0%). Similar proportions of DBT- and DM-recalled lesions were assessed using ultrasound (76.3% vs 71.4%). Conclusion Assessment of screen-recalled lesions showed that, compared with DM, DBT found more benign and more malignant lesions, and generally required more procedures except for less additional mammography workup. These findings show that a transition to DBT screening changes the assessment workload.

Purpose: Breast cancer is the most common cancer in women in developing and developed countries and is responsible for 15% of women’s cancer deaths worldwide. Conventional absorption-based breast imaging techniques lack sufficient contrast for comprehensive diagnosis. Propagation-based phase-contrast computed tomography (PB-CT) is a developing technique that exploits a more contrast-sensitive property of x-rays: x-ray refraction. X-ray absorption, refraction, and contrast-to-noise in the corresponding images depend on the x-ray energy used, for the same/fixed radiation dose. The aim of this paper is to explore the relationship between x-ray energy and radiological image quality in PB-CT imaging. Approach: Thirty-nine mastectomy samples were scanned at the imaging and medical beamline at the Australian Synchrotron. Samples were scanned at various x-ray energies of 26, 28, 30, 32, 34, and 60 keV using a Hamamatsu Flat Panel detector at the same object-to-detector distance of 6 m and mean glandular dose of 4 mGy. A total of 132 image sets were produced for analysis. Seven observers rated PB-CT images against absorption-based CT (AB-CT) images of the same samples on a five-point scale. A visual grading characteristics (VGC) study was used to determine the difference in image quality. Results: PB-CT images produced at 28, 30, 32, and 34 keV x-ray energies demonstrated statistically significant higher image quality than reference AB-CT images. The optimum x-ray energy, 30 keV, displayed the largest area under the curve [Formula: see text] of 0.754 ([Formula: see text]). This was followed by 32 keV ([Formula: see text] , [Formula: see text]), 34 keV ([Formula: see text] , [Formula: see text]), and 28 keV ([Formula: see text] , [Formula: see text]). Conclusions: An optimum energy range (around 30 keV) in the PB-CT technique allows for higher image quality at a dose comparable to conventional mammographic techniques. This results in improved radiological image quality compared with conventional techniques, which may ultimately lead to higher diagnostic efficacy and a reduction in breast cancer mortalities.

Propagation-based phase-contrast CT (PB-CT) is a novel imaging technique that visualises variations in both X-ray attenuation and refraction. This study aimed to compare the clinical image quality of breast PB-CT using synchrotron radiation with conventional absorption-based CT (AB-CT), at the same radiation dose. Seven breast mastectomy specimens were scanned and evaluated by a group of 14 radiologists and medical imaging experts who assessed the images based on seven radiological image quality criteria. Visual grading characteristics (VGC) were used to analyse the results and the area under the VGC curve was obtained to measure the differences between the two techniques. For six image quality criteria (overall quality, perceptible contrast, lesion sharpness, normal tissue interfaces, calcification visibility and image noise), PB-CT images were superior to AB-CT images of the same dose (AUCVGC: 0.704 to 0.914, P≤.05). For the seventh criteria (artefacts), PB-CT images were also rated better than AB-CT images (AUCVGC: 0.647) but the difference was not significant. The results of this study provide a solid basis for future experimental and clinical protocols of breast PB-CT.

The purpose of this article is to review different x-ray phase-contrast breast imaging techniques and their potential application in clinical settings.Phase-contrast imaging depicts not only the absorption contrast but also the refraction contrast of the transmitted x-ray beam. Early data suggest that this new modality may overcome some of the diagnostic limitations associated with current clinically available mammography systems and that it has potential for improving breast cancer detection.

To evaluate and compare the image quality of propagation-based phase-contrast computed tomography (PB-CT) using synchrotron radiation and conventional cone-beam breast computed tomography (CBBCT) based on various radiological image quality criteria. Eight excised breast tissue samples of various sizes and containing different lesion types were scanned using PB-CT at a synchrotron facility and using CBBCT at a university-affiliated breast imaging centre. PB-CT scans were performed at two different mean glandular dose (MGD) levels: standard (5.8 mGy) and low (1.5 mGy), for comparison with CBBCT scans at the standard MGD (5.8 mGy). Image quality assessment was carried out using six quality criteria and six independent medical imaging experts in a reading room with mammography workstations. The interobserver agreement between readers was evaluated using intraclass correlation coefficient (ICC), and image quality was compared between the two breast imaging modalities using the area under the visual grading characteristic curve (AUCVGC). Interobserver agreement between the readers showed moderate reliability for five image criteria (ICC: ranging from 0.488 to 0.633) and low reliability for one criterion (image noise) (ICC 0.307). For five image quality criteria (overall quality, perceptible contrast, lesion sharpness, normal tissue interfaces, and calcification visibility), both standard-dose PB-CT images (AUCVGC 0.958 to 1, p ≤ .05) and low dose PB-CT images (AUCVGC 0.785 to 0.834, p ≤ .05) were of significantly higher image quality than standard-dose CBBCT images. Synchrotron-based PB-CT can achieve a significantly higher radiological image quality at a substantially lower radiation dose compared with conventional CBBCT. • PB-CT using synchrotron radiation results in higher image quality than conventional CBBCT for breast imaging. • PB-CT using synchrotron radiation requires a lower radiation dose than conventional CBBCT for breast imaging. • PB-CT can help clinicians diagnose patients with breast cancer.

PURPOSE Propagation-based phase-contrast computed tomography (PB-CT) is a method for three-dimensional x-ray imaging that utilizes refraction, as well as absorption, of x rays in the tissues to increase the signal-to-noise ratio (SNR) in the resultant images, in comparison with equivalent conventional absorption-only x-ray tomography (CT). Importantly, the higher SNR is achieved without sacrificing spatial resolution or increasing the radiation dose delivered to the imaged tissues. The present work has been carried out in the context of the current development of a breast CT imaging facility at the Australian Synchrotron. METHODS Seven unfixed complete mastectomy samples with and without breast cancer lesions have been imaged using absorption-only CT and PB-CT techniques under controlled experimental conditions. The radiation doses delivered to the mastectomy samples during the scans were comparable to those approved for mammographic screening. Physical characteristics of the reconstructed images, such as spatial resolution and SNR, have been measured and compared with the results of the radiological quality assessment of the complete absorption CT and PB-CT image stacks. RESULTS Despite the presence of some image artefacts, the PB-CT images have outperformed comparable absorption CT images collected at the same radiation dose, in terms of both the measured objective image characteristics and the radiological image scores. The outcomes of these experiments are shown to be consistent with predictions of the theory of PB-CT imaging and previous reported experimental studies of this imaging modality. CONCLUSIONS The results presented in this paper demonstrate that PB-CT holds a high potential for improving on the quality and diagnostic value of images obtained using existing medical x-ray technologies, such as mammography and digital breast tomosynthesis (DBT). If implemented at suitable synchrotron imaging facilities, PB-CT can be used to complement existing imaging modalities, leading to more accurate breast cancer diagnosis.

The aim of this study was to optimise the experimental protocol and data analysis for in-vivo breast cancer x-ray imaging. Results are presented of the experiment at the SYRMEP beamline of Elettra Synchrotron using the propagation-based phase-contrast mammographic tomography method, which incorporates not only absorption, but also x-ray phase information. In this study the images of breast tissue samples, of a size corresponding to a full human breast, with radiologically acceptable x-ray doses were obtained, and the degree of improvement of the image quality (from the diagnostic point of view) achievable using propagation-based phase-contrast image acquisition protocols with proper incorporation of x-ray phase retrieval into the reconstruction pipeline was investigated. Parameters such as the x-ray energy, sample-to-detector distance and data processing methods were tested, evaluated and optimized with respect to the estimated diagnostic value using a mastectomy sample with a malignant lesion. The results of quantitative evaluation of images were obtained by means of radiological assessment carried out by 13 experienced specialists. A comparative analysis was performed between the x-ray and the histological images of the specimen. The results of the analysis indicate that, within the investigated range of parameters, both the objective image quality characteristics and the subjective radiological scores of propagation-based phase-contrast images of breast tissues monotonically increase with the strength of phase contrast which in turn is directly proportional to the product of the radiation wavelength and the sample-to-detector distance. The outcomes of this study serve to define the practical imaging conditions and the CT reconstruction procedures appropriate for low-dose phase-contrast mammographic imaging of live patients at specially designed synchrotron beamlines.

Objectives To estimate detection measures for tomosynthesis and standard mammography; to assess the feasibility of using tomosynthesis in population-based screening for breast cancer. Design, setting Prospective pilot trial comparing tomosynthesis (with synthesised 2D images) and standard mammography screening of women attending Maroondah BreastScreen, a BreastScreen Victoria service in the eastern suburbs of Melbourne. Participants Women at least 40 years of age who presented for routine breast screening between 18 August 2017 and 8 November 2018. Main outcome measures Cancer detection rate (CDR); proportion of screens that led to recall for further assessment. Results 5018 tomosynthesis and 5166 standard mammography screens were undertaken in 10 146 women; 508 women (5.0% of screens) opted not to undergo tomosynthesis screening. With tomosynthesis, 49 cancers (40 invasive, 9 in situ) were detected (CDR, 9.8 [95% CI, 7.2-13] per 1000 screens); with standard mammography, 34 cancers (30 invasive, 4 in situ) were detected (CDR, 6.6 [95% CI, 4.6-9.2] per 1000 screens). The estimated difference in CDR was 3.2 more detections (95% CI, -0.32 to 6.8) per 1000 screens with tomosynthesis; the difference was greater for repeat screens and for women aged 60 years or more. The recall rate was greater for tomosynthesis (4.2%; 95% CI, 3.6-4.8%) than standard mammography (3.0%; 95% CI, 2.6-3.5%; estimated difference, 1.2%; 95% CI, 0.46-1.9%). The median screen reading time for tomosynthesis was 67 seconds (interquartile range [IQR] 46-105 seconds); for standard mammography, 16 seconds (IQR, 10-29 seconds). Conclusions Breast cancer detection, recall for assessment, and screen reading time were each higher for tomosynthesis than for standard mammography. Our preliminary findings could form the basis of a large scale comparative evaluation of tomosynthesis and standard mammography for breast screening in Australia. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12617000947303.

Rationale and Objectives This study employs clinical/radiological evaluation in establishing the optimum imaging conditions for breast cancer imaging using the X-ray propagation-based phase-contrast tomography. Materials and Methods Two series of experiments were conducted and in total 161 synchrotron-based computed tomography (CT) reconstructions of one breast mastectomy specimen were produced at different imaging conditions. Imaging factors include sample-to-detector distance, X-ray energy, CT reconstruction method, phase retrieval algorithm applied to the CT projection images and maximum intensity projection. Observers including breast radiologists and medical imaging experts compared the quality of the reconstructed images with reference images approximating the conventional (absorption) CT. Various radiological image quality attributes in a visual grading analysis design were used for the radiological assessments. Results The results show that the application of the longest achievable sample-to-detector distance (9.31 m), the lowest employed X-ray energy (32 keV), the full phase retrieval, and the maximum intensity projection can significantly improve the radiological quality of the image. Several combinations of imaging variables resulted in images with very high-quality scores. Conclusion The results of the present study will support future experimental and clinical attempts to further optimize this innovative approach to breast cancer imaging.

The aim of this study was to highlight the advantages that propagation-based phase-contrast computed tomography (PB-CT) with synchrotron radiation can provide in breast cancer diagnostics. For the first time, a fresh and intact mastectomy sample from a 60 year old patient was scanned on the IMBL beamline at the Australian Synchrotron in PB-CT mode and reconstructed. The clinical picture was described and characterized by an experienced breast radiologist, who underlined the advantages of providing diagnosis on a PB-CT volume rather than conventional two-dimensional modalities. Subsequently, the image quality was assessed by 11 breast radiologists and medical imaging experts using a radiological scoring system. The results indicate that, with the radiation dose delivered to the sample being equal, the accuracy of a diagnosis made on PB-CT images is significantly higher than one using conventional techniques.

We present the outcomes of combined feasibility studies carried out at Elettra and Australian Synchrotron to evaluate novel protocols for threedimensional (3D) mammographic phase contrast imaging. A custom designed plastic phantom and some tissue samples have been studied at diverse resolution scales and experimental conditions. Several computed tomography (CT) reconstruction algorithms with different pre-processing and post-processing steps have been considered. Special attention was paid to the effect of phase retrieval on the diagnostic value of the reconstructed images. The images were quantitatively evaluated using objective quality indices in comparison with subjective assessments performed by three experienced radiologists and one pathologist. We show that the propagation-based phase-contrast imaging (PBI) leads to substantial improvement to the contrast-to-noise and to the intrinsic quality of the reconstructed CT images compared with conventional techniques as well as to an important reduction of the delivered doses, thus opening the way to clinical implementations.

Results are presented of a recent experiment at the Imaging and Medical beamline of the Australian Synchrotron intended to contribute to the implementation of low-dose high-sensitivity three-dimensional mammographic phase-contrast imaging, initially at synchrotrons and subsequently in hospitals and medical imaging clinics. The effect of such imaging parameters as X-ray energy, source size, detector resolution, sample-to-detector distance, scanning and data processing strategies in the case of propagation-based phase-contrast computed tomography (CT) have been tested, quantified, evaluated and optimized using a plastic phantom simulating relevant breast-tissue characteristics. Analysis of the data collected using a Hamamatsu CMOS Flat Panel Sensor, with a pixel size of 100 µm, revealed the presence of propagation-based phase contrast and demonstrated significant improvement of the quality of phase-contrast CT imaging compared with conventional (absorption-based) CT, at medically acceptable radiation doses.

We report the results of a systematic study of phase-contrast x-ray computed tomography in the propagation-based and analyser-based modes using specially designed phantoms and excised breast tissue samples. The study is aimed at the quantitative evaluation and subsequent optimization, with respect to detection of small tumours in breast tissue, of the effects of phase contrast and phase retrieval on key imaging parameters, such as spatial resolution, contrast-to-noise ratio, x-ray dose and a recently proposed ‘intrinsic quality’ characteristic which combines the image noise with the spatial resolution. We demonstrate that some of the methods evaluated in this work lead to substantial (more than 20-fold) improvement in the contrast-to-noise and intrinsic quality of the reconstructed tomographic images compared with conventional techniques, with the measured characteristics being in good agreement with the corresponding theoretical estimations. This improvement also corresponds to an approximately 400-fold reduction in the x-ray dose, compared with conventional absorption-based tomography, without a loss in the imaging quality. The results of this study confirm and quantify the significant potential benefits achievable in three-dimensional mammography using x-ray phase-contrast imaging and phase-retrieval techniques.

Results are presented of a feasibility study of three-dimensional X-ray tomographic mammography utilising in-line phase contrast. Experiments were performed at SYRMEP beamline of Elettra synchrotron. A specially designed plastic phantom and a mastectomy sample containing a malignant lesion were used to study the reconstructed image quality as a function of different image processing operations. Detailed evaluation and optimization of image reconstruction workflows have been carried out using combinations of several advanced computed tomography algorithms with different pre-processing and post-processing steps. Special attention was paid to the effect of phase retrieval on the diagnostic value of the reconstructed images. A number of objective image quality indices have been applied for quantitative evaluation of the results, and these were compared with subjective assessments of the same images by three experienced radiologists and one pathologist. The outcomes of this study provide practical guidelines for the optimization of image processing workflows in synchrotron-based phase-contrast mammo-tomography.