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Objectives: To investigate the influence of preoperative breast MRI on mastectomy and reoperation rates in patients with pure ductal carcinoma in situ (DCIS)., Methods: The MIPA observational study database (7245 patients) was searched for patients aged 18-80 years with pure unilateral DCIS diagnosed at core needle or vacuum-assisted biopsy (CNB/VAB) and planned for primary surgery. Patients who underwent preoperative MRI (MRI group) were matched (1:1) to those who did not receive MRI (noMRI group) according to 8 confounding covariates that drive referral to MRI (age; hormonal status; familial risk; posterior-to-nipple diameter; BI-RADS category; lesion diameter; lesion presentation; surgical planning at conventional imaging). Surgical outcomes were compared between the matched groups with nonparametric statistics after calculating odds ratios (ORs)., Results: Of 1005 women with pure unilateral DCIS at CNB/VAB (507 MRI group, 498 noMRI group), 309 remained in each group after matching. First-line mastectomy rate in the MRI group was 20.1% (62/309 patients, OR 2.03) compared to 11.0% in the noMRI group (34/309 patients, p = 0.003). The reoperation rate was 10.0% in the MRI group (31/309, OR for reoperation 0.40) and 22.0% in the noMRI group (68/309, p < 0.001), with a 2.53 OR of avoiding reoperation in the MRI group. The overall mastectomy rate was 23.3% in the MRI group (72/309, OR 1.40) and 17.8% in the noMRI group (55/309, p = 0.111)., Conclusions: Compared to those going directly to surgery, patients with pure DCIS at CNB/VAB who underwent preoperative MRI had a higher OR for first-line mastectomy but a substantially lower OR for reoperation., Clinical Relevance Statement: When confounding factors behind MRI referral are accounted for in the comparison of patients with CNB/VAB-diagnosed pure unilateral DCIS, preoperative MRI yields a reduction of reoperations that is more than twice as high as the increase in overall mastectomies., Key Points: • Confounding factors cause imbalance when investigating the influence of preoperative MRI on surgical outcomes of pure DCIS. • When patient matching is applied to women with pure unilateral DCIS, reoperation rates are significantly reduced in women who underwent preoperative MRI. • The reduction of reoperations brought about by preoperative MRI is more than double the increase in overall mastectomies., (© 2023. The Author(s).)

Objectives: To report mastectomy and reoperation rates in women who had breast MRI for screening (S-MRI subgroup) or diagnostic (D-MRI subgroup) purposes, using multivariable analysis for investigating the role of MRI referral/nonreferral and other covariates in driving surgical outcomes., Methods: The MIPA observational study enrolled women aged 18-80 years with newly diagnosed breast cancer destined to have surgery as the primary treatment, in 27 centres worldwide. Mastectomy and reoperation rates were compared using non-parametric tests and multivariable analysis., Results: A total of 5828 patients entered analysis, 2763 (47.4%) did not undergo MRI (noMRI subgroup) and 3065 underwent MRI (52.6%); of the latter, 2441/3065 (79.7%) underwent MRI with preoperative intent (P-MRI subgroup), 510/3065 (16.6%) D-MRI, and 114/3065 S-MRI (3.7%). The reoperation rate was 10.5% for S-MRI, 8.2% for D-MRI, and 8.5% for P-MRI, while it was 11.7% for noMRI (p ≤ 0.023 for comparisons with D-MRI and P-MRI). The overall mastectomy rate (first-line mastectomy plus conversions from conserving surgery to mastectomy) was 39.5% for S-MRI, 36.2% for P-MRI, 24.1% for D-MRI, and 18.0% for noMRI. At multivariable analysis, using noMRI as reference, the odds ratios for overall mastectomy were 2.4 (p < 0.001) for S-MRI, 1.0 (p = 0.957) for D-MRI, and 1.9 (p < 0.001) for P-MRI., Conclusions: Patients from the D-MRI subgroup had the lowest overall mastectomy rate (24.1%) among MRI subgroups and the lowest reoperation rate (8.2%) together with P-MRI (8.5%). This analysis offers an insight into how the initial indication for MRI affects the subsequent surgical treatment of breast cancer., Key Points: • Of 3065 breast MRI examinations, 79.7% were performed with preoperative intent (P-MRI), 16.6% were diagnostic (D-MRI), and 3.7% were screening (S-MRI) examinations. • The D-MRI subgroup had the lowest mastectomy rate (24.1%) among MRI subgroups and the lowest reoperation rate (8.2%) together with P-MRI (8.5%). • The S-MRI subgroup had the highest mastectomy rate (39.5%) which aligns with higher-than-average risk in this subgroup, with a reoperation rate (10.5%) not significantly different to that of all other subgroups., (© 2023. The Author(s).)

Objectives: Preoperative breast magnetic resonance imaging (MRI) can inform surgical planning but might cause overtreatment by increasing the mastectomy rate. The Multicenter International Prospective Analysis (MIPA) study investigated this controversial issue., Methods: This observational study enrolled women aged 18-80 years with biopsy-proven breast cancer, who underwent MRI in addition to conventional imaging (mammography and/or breast ultrasonography) or conventional imaging alone before surgery as routine practice at 27 centers. Exclusion criteria included planned neoadjuvant therapy, pregnancy, personal history of any cancer, and distant metastases., Results: Of 5896 analyzed patients, 2763 (46.9%) had conventional imaging only (noMRI group), and 3133 (53.1%) underwent MRI that was performed for diagnosis, screening, or unknown purposes in 692/3133 women (22.1%), with preoperative intent in 2441/3133 women (77.9%, MRI group). Patients in the MRI group were younger, had denser breasts, more cancers ≥ 20 mm, and a higher rate of invasive lobular histology than patients who underwent conventional imaging alone (p < 0.001 for all comparisons). Mastectomy was planned based on conventional imaging in 22.4% (MRI group) versus 14.4% (noMRI group) (p < 0.001). The additional planned mastectomy rate in the MRI group was 11.3%. The overall performed first- plus second-line mastectomy rate was 36.3% (MRI group) versus 18.0% (noMRI group) (p < 0.001). In women receiving conserving surgery, MRI group had a significantly lower reoperation rate (8.5% versus 11.7%, p < 0.001)., Conclusions: Clinicians requested breast MRI for women with a higher a priori probability of receiving mastectomy. MRI was associated with 11.3% more mastectomies, and with 3.2% fewer reoperations in the breast conservation subgroup., Key Points: • In 19% of patients of the MIPA study, breast MRI was performed for screening or diagnostic purposes. • The current patient selection to preoperative breast MRI implies an 11% increase in mastectomies, counterbalanced by a 3% reduction of the reoperation rate. • Data from the MIPA study can support discussion in tumor boards when preoperative MRI is under consideration and should be shared with patients to achieve informed decision-making., (© 2021. The Author(s).)

To compare microvascular flow imaging (MVFI) to conventional Color-Doppler (CDI) and Power-Doppler (PDI) imaging in the detection of vascularity of Focal Breast Lesions (FBLs). A total of 180 solid FBLs (size: 3.5-45.2 mm) detected in 180 women (age: 21-87 years) were evaluated by means of CDI, PDI, and MVFI. Two blinded reviewers categorized lesion vascularity in absent or present, and vascularity pattern as (a) internal; (b) vessels in rim; (c) combined. The presence of a "penetrating vessel" was assessed separately. Differences in vascularization patterns (chi 2 test) and intra- and inter-observer agreement (Fleiss method) were calculated. ROC analysis was performed to assess performance of each technique in differentiating benign from malignant lesions. About 103/180 (57.2%) FBLs were benign and 77/180 (42.8%) were malignant. A statistically significant ( p  < .001) increase in blood flow detection was observed for both readers with MVFI in comparison to either CDI or PDI. Benign FBLs showed mainly absence of vascularity ( p   =  .02 and p   =  .01 for each reader, respectively), rim pattern ( p  < .001 for both readers) or combined pattern ( p  = .01 and p  = .04). Malignant lesions showed a statistically significant higher prevalence of internal flow pattern ( p  < .001 for both readers). The prevalence of penetrating vessels was significantly higher with MVFI in comparison to either CDI or PDI ( p  < .001 for both readers) and in the malignant FBLs ( p  < .001). ROC analysis showed MVFI (AUC = 0.70, 95%CI = [0.64-0.77]) more accurate than CDI (AUC = 0.67, 95%CI = [0.60-0.74]) and PDI (AUC = 0.67, 95%CI = [0.60-0.74]) though not significantly ( p  = .5436). Sensitivity/Specificity values for MVFI, PDI, and CDI were 76.6%/64.1%, 59.7%/73.8% and 58.4%/74.8%, respectively. Inter-reader agreement with MVFI was always very good ( k -score 0.85-0.96), whereas with CDI and PDI evaluation ranged from good to very good. No differences in intra-observer agreement were noted. MVFI showed a statistically significant increase in the detection of the vascularization of FBLs in comparison to Color and Power-Doppler.

Background: To assess inter-reader agreement for US BI-RADS descriptors using S-Detect: a computer-guided decision-making software assisting in US morphologic analysis., Methods: 73 solid focal breast lesions (FBLs) (mean size: 15.9 mm) in 73 consecutive women (mean age: 51 years) detected at US were randomly and independently assessed according to the BI-RADS US lexicon, without and with S-Detect, by five independent reviewers. US-guided core-biopsy and 24-month follow-up were considered as standard of reference. Kappa statistics were calculated to assess inter-operator agreement, between the baseline and after S-Detect evaluation. Agreement was graded as poor (≤ 0.20), moderate (0.21-0.40), fair (0.41-0.60), good (0.61-0.80), or very good (0.81-1.00)., Results: 33/73 (45.2%) FBLs were malignant and 40/73 (54.8%) FBLs were benign. A statistically significant improvement of inter-reader agreement from fair to good with the use of S-Detect was observed for shape (from 0.421 to 0.612) and orientation (from 0.417 to 0.7) (p < 0.0001) and from moderate to fair for margin (from 0.204 to 0.482) and posterior features (from 0.286 to 0.522) (p < 0.0001). At baseline analysis isoechoic (0.0485) and heterogeneous (0.1978) echo pattern, microlobulated (0.1161) angular (0.1204) and spiculated (0.1692) margins and combined pattern (0.1549) for posterior features showed the worst agreement rate (poor). After S-Detect evaluation, all variables but isoechoic pattern showed an agreement class upgrade with a statistically significant improvement of inter-reader agreement (p < 0.0001)., Conclusions: S-Detect significantly improved inter-reader agreement in the assessment of FBLs according to the BI-RADS US lexicon but evaluation of margin and echo pattern needs to be further improved, particularly isoechoic pattern.

Despite its high diagnostic performance, the use of breast MRI in the preoperative setting is controversial. It has the potential for personalized surgical management in breast cancer patients, but two of three randomized controlled trials did not show results in favor of its introduction for assessing the disease extent before surgery. Meta-analyses showed a higher mastectomy rate in women undergoing preoperative MRI compared to those who do not. Nevertheless, preoperative breast MRI is increasingly used and a survey from the American Society of Breast Surgeons showed that 41% of respondents ask for it in daily practice. In this context, a large-scale observational multicenter international prospective analysis (MIPA study) was proposed under the guidance of the European Network for the Assessment of Imaging in Medicine (EuroAIM). The aims were (1) to prospectively and systematically collect data on consecutive women with a newly diagnosed breast cancer, not candidates for neoadjuvant therapy, who are offered or not offered breast MRI before surgery according to local practice; (2) to compare these two groups in terms of surgical and clinical endpoints, adjusting for covariates. The underlying hypotheses are that MRI does not cause additional mastectomies compared to conventional imaging, while reducing the reoperation rate in all or in subgroups of patients. Ninety-six centers applied to a web-based call; 36 were initially selected based on volume and quality standards; 27 were active for enrollment. On November 2018, the target of 7000 enrolled patients was reached. The MIPA study is presently at the analytic phase. Key Points • Breast MRI has a high diagnostic performance but its utility in the preoperative setting is controversial. • A large-scale observational multicenter prospective study was launched to compare women receiving with those not receiving preoperative MRI. • Twenty-seven centers enrolled more than 7000 patients. The study is presently at the analytic phase.

Purpose: This study was undertaken to evaluate the role of ultrasound (US) elastography in characterising focal breast lesions classified as indeterminate on B-mode US., Materials and Methods: Eighty-four focal breast lesions, 64 benign and 20 malignant (mean diameter, 15.1 mm), detected but not characterised on B-mode US in 72 women, Breast Imaging Reporting and Data System (BI-RADS) US category 3 (n=56) or category 4 (n=28), were studied with US elastography and classified in consensus by two radiologists according to a five-point colour scale. Sensitivity, specificity and positive and negative predictive values (PPV and NPV) of US elastography compared with conventional US were calculated in relation to microhistology (n=67) and cytology (n=17), which were used as the reference standard., Results: A total of 65/84 (77.4%) lesions were correctly classified as benign or malignant using US elastography, whereas the remaining 19/84 (22.6%) were incorrectly assessed. There were no statistically significant differences between US elastography and B-mode US with regard to sensitivity (70% vs. 68.4%), specificity (79.6% vs. 78.5%), PPV (51.8% vs. 48.1%) and NPV 89% vs. 89.5% (p>0.5). By contrast, a statistically significant difference was noted in the evaluation of BI-RADS 3 lesions, in which US elastography had 50% sensitivity, 86% specificity, 30% PPV and 93.5% NPV compared with BI-RADS 4 lesions (78.6%, 57.1%, 64.7% and 72.7%) (p<0.5)., Conclusions: The high NPV of US elastography may help reduce the use of biopsy in BI-RADS 3 lesions, but its low PPV in BI-RADS 4 lesions does not allow avoidance of biopsy on the basis of the US elastographic score alone in this group of lesions.

Purpose: Direct measurement of mammographic x-ray spectra under clinical conditions is a difficult task due to the high fluence rate of the x-ray beams as well as the limits in the development of high resolution detection systems in a high counting rate environment. In this work we present a detection system, based on a CdTe detector and an innovative digital pulse processing (DPP) system, for high-rate x-ray spectroscopy in mammography., Methods: The DPP system performs a digital pile-up inspection and a digital pulse height analysis of the detector signals, digitized through a 14-bit, 100 MHz digitizer, for x-ray spectroscopy even at high photon counting rates. We investigated on the response of the digital detection system both at low (150 cps) and at high photon counting rates (up to 500 kcps) by using monoenergetic x-ray sources and a nonclinical molybdenum anode x-ray tube. Clinical molybdenum x-ray spectrum measurements were also performed by using a pinhole collimator and a custom alignment device., Results: The detection system shows excellent performance up to 512 kcps with an energy resolution of 4.08% FWHM at 22.1 keV. Despite the high photon counting rate (up to 453 kcps), the molybdenum x-ray spectra, measured under clinical conditions, are characterized by a low number of pile-up events. The agreement between the attenuation curves and the half value layer values, obtained from the measured spectra, simulated spectra, and from the exposure values directly measured with an ionization chamber, also shows the accuracy of the measurements., Conclusions: These results make the proposed detection system a very attractive tool for both laboratory research and advanced quality controls in mammography.

Purpose: The study compares the diagnostic accuracy (correct identification of cancer) of a new computer-assisted diagnosis (CAD) system (Cyclopus) with two other commercial systems (R2 and CADx)., Materials and Methods: Cyclopus was tested on a set of 120 mammograms on which the two compared commercial systems had been previously tested. The set consisted of mammograms reported as negative, preceding 31 interval cancers reviewed as screening error or minimal sign, and of 89 verified negative controls randomly selected from the same screening database., Results: Cyclopus sensitivity was 74.1% (R2=54.8%; CADx=41.9%) and was higher for interval cancers reviewed as screening error (90.9%; R2=54.5%; CADx=81.8%) compared with those reviewed as minimal sign (65.0%; R2=55.0%; CADx=20.0%). Specificity was 15.7% (R2=29.2%; CADx=17.9%). Overall accuracy was 30.8% (R2=35.8%; CADx=24.1%). The positive predictive value of a case with CAD marks [regions of interest (ROI)] was 23.4% (23/98; R2=16.0%; CADx=15.1%). Average ROI number per view among negative controls was 1.13 (R2=0.93; CADx=0.99). Cyclopus was more sensitive for masses compared with isolated microcalcifications (208 vs 62 ROI; R2=90 vs 213; CADx=192 vs 130)., Conclusions: Compared with two other commercial systems, Cyclopus was more sensitive (R2 p=0.14; CADx p=0.02) and less specific (R2 p=0.02; CADx p=0.64).

The clinical use of breast magnetic resonance (MR) imaging is increasing, especially for applications requiring paramagnetic contrast-agent injection. This document presents a synthetic list of acceptable indications with potential advantages for women according to evidence from the literature and the expert opinion of the panel that developed this statement. We generally recommend that breast MR imaging be performed in centres with experience in conventional breast imaging [mammography and ultrasonography (US)] and needle-biopsy procedures (under stereotactic or US guidance) as well as in breast MR imaging and second-look US for findings not revealed by conventional imaging performed before MR imaging. In our opinion, there is no evidence in favour of breast MR imaging as a diagnostic tool to characterise equivocal findings at conventional imaging when needle-biopsy procedures can be performed, nor for the study of asymptomatic, non-high-risk women with negative conventional imaging. After a description of technical and methodological requirements, we define the indications and limitations of breast MR imaging for surveillance of high-risk women, local staging before surgery, evaluation of the effect of neoadjuvant chemotherapy, breast previously treated for carcinoma, carcinoma of unknown primary syndrome, nipple discharge and breast implants.

The implementation of a database of digitised mammograms is discussed. The digitised images were collected beginning in 1999 by a community of physicists in collaboration with radiologists in several Italian hospitals as a first step in developing and implementing a computer-aided detection (CAD) system. All 3,369 mammograms were collected from 967 patients and classified according to lesion type and morphology, breast tissue and pathology type. A dedicated graphical user interface was developed to visualise and process mammograms to support the medical diagnosis directly on a high-resolution screen. The database has been the starting point for developing other medical imaging applications, such as a breast CAD, currently being upgraded and optimised for use in a distributed environment with grid services, in the framework of the Instituto Nazionale di Fisicia Nucleare (INFN)-funded Medical Applications on a Grid Infrastructure Connection (MAGIC)-5 project.

Purpose: To evaluate the role of high frequency colour-Doppler ultrasound in the study of diffuse or local breast nodules in males, and compare these results with those of mammography., Materials and Methods: We studied 105 men aged between 12 and 82 years (mean age 42.3 years) with a palpable breast mass with or without pain. All patients underwent clinical and ultrasound examination. Seventy-eight also underwent mammography, whereas 27 did not because of young age (under 25 years) (n=10), no clinical or sonographic suspicion of a malignant mass (n=16), and ulcerated neoplastic lesion (n=1). The final diagnosis derived from surgery in six patients and from three-year follow-up for 99 patients., Results: Eighty-nine patients had gynecomastia (85%), nine had adipomastia (8%), one had fibrolipoma (1%), five had carcinoma (5%) (invasive ductal carcinoma in four and bifocal ductal carcinoma and lobular carcinoma in one patient) and one had liposarcoma (1%). The clinical examination detected a bilateral (n=66) or unilateral (n=39) breast mass. Ultrasonography provided the correct diagnosis of diffuse nodular pathology in all cases and orientated diagnosis towards malignancy (6 cases) or benignity (1 case) of the lesions. No additional information was obtained from mammography, as compared to high-frequency ultrasonography. The integration of colour-Doppler in the examination was of little use as it demonstrated extensive vascularisation of most (5 cases) of the malignant lesions., Conclusions: Our results indicate that ultrasound allows the detection and characterization of palpable breast masses as well as correct local staging of neoplasms by identifying the degree of infiltration of the surrounding tissues.

Purpose: To characterise breast lesions on the basis of microcirculation features detected with contrast-enhanced US., Materials and Methods: Thirty-six patients aged 42-63 years (mean age 55 years) with a single breast lesion previously detected at standard mammography were studied. All US examinations were performed using an ATL HDI 5000 ultrasound device with a 5-10 MHz linear-array transducer, before and after administration of ultrasound contrast medium Levovist (Schering(R), Berlin) was administered by bolus injection (2 ml/s) via a 20 G catheter probe. The mechanical index was set to high to obtain instant rupture of the microbubbles under insonation. Intensity/time curves of the transient scattering in the region of interest (ROI) after contrast administration were extrapolated. The areas under the ROI curves were also evaluated to quantitatively assess the scattering., Results: The US baseline study and colour Doppler US identified 19 benign lesions (15 histologically proven) and 17 malignant lesions (16 histologically proven). The administration of contrast medium did not improve the specificity of the examination. Only by plotting the intensity/time curves of the regions of interest (ROI) and evaluating the areas under the ROI curves, was a significant correlation detected between US and histopathologic diagnosis., Conclusions: Although further evaluation on a larger series is needed, the analysis of breast lesions by contrast-enhanced perfusion US seems to be a promising technique. Perfusion US can usefully complement high-frequency US, especially when mammography is inconclusive.