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PURPOSE: We present a comprehensive investigation into the organizational, social, and ethical impact of implementing digital breast tomosynthesis (DBT) as a primary test for breast cancer screening in Italy. The analyses aimed to assess the feasibility of DBT specifically for all women aged 45-74, women aged 45-49 only, or those with dense breasts only. METHODS: Questions were framed according to the European Network of Health Technology Assessment (EuNetHTA) Screening Core Model to produce evidence for the resources, equity, acceptability, and feasibility domains of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) decision framework. The study integrated evidence from the literature, the MAITA DBT trials, and Italian pilot programs. Structured interviews, surveys, and systematic reviews were conducted to gather data on organizational impact, acceptability among women, reading and acquisition times, and the technical requirements of DBT in screening. RESULTS: Implementing DBT could significantly affect the screening program, primarily due to increased reading times and the need for additional human resources (radiologists and radiographers). Participation rates in DBT screening were similar, if not better, to those observed with standard digital mammography, indicating good acceptability among women. The study also highlighted the necessity for specific training for radiographers. The interviewed key persons unanimously considered feasible tailored screening strategies based on breast density or age, but they require effective communication with the target population. CONCLUSIONS: An increase in radiologists' and radiographers' workload limits the feasibility of DBT screening. Tailored screening strategies may maximize the benefits of DBT while mitigating potential challenges.
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Neoplasias da Mama , Detecção Precoce de Câncer , Mamografia , Humanos , Feminino , Neoplasias da Mama/diagnóstico por imagem , Itália , Mamografia/métodos , Pessoa de Meia-Idade , Idoso , Detecção Precoce de Câncer/métodos , Estudos de ViabilidadeRESUMO
PURPOSE: Contrast-enhanced digital mammography (CEDM) is a relatively new imaging technique recombining low- and high-energy mammograms to emphasise iodine contrast. This work aims to perform a multicentric physical and dosimetric characterisation of four state-of-the-art CEDM systems. METHODS: We evaluated tube output, half-value-layer (HVL) for low- and high-energy and average glandular dose (AGD) in a wide range of equivalent breast thicknesses. CIRS phantom 022 was used to estimate the overall performance of a CEDM examination in the subtracted image in terms of the iodine difference signal (S). To calculate dosimetric impact of CEDM examination, we collected 4542 acquisitions on patients. RESULTS: Even if CEDM acquisition strategies differ, all the systems presented a linear behaviour between S and iodine concentration. The curve fit slopes expressed in PV/mg/cm2 were in the range [92-97] for Fujifilm, [31-32] for GE Healthcare, [35-36] for Hologic, and [114-130] for IMS. Dosimetric data from patients were matched with AGD values calculated using equivalent PMMA thicknesses. Fujifilm exhibited the lowest values, while GE Healthcare showed the highest. CONCLUSION: The subtracted image showed the ability of all the systems to give important information about the linearity of the signal with the iodine concentrations. All the patient-collected doses were under the AGD EUREF 2D Acceptable limit, except for patients with thicknesses ≤35 mm belonging to GE Healthcare and Hologic, which were slightly over. This work demonstrates the importance of testing each CEDM system to know how it performs regarding dose and the relationship between PV and iodine concentration.
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Neoplasias da Mama , Iodo , Humanos , Feminino , Intensificação de Imagem Radiográfica/métodos , Meios de Contraste , Mamografia/métodos , Mama , Imagens de FantasmasRESUMO
Background: Image-derived artificial intelligence (AI)-based risk models for breast cancer have shown high discriminatory performances compared with clinical risk models based on family history and lifestyle factors. However, little is known about their generalizability across European screening settings. We therefore investigated the discriminatory performances of an AI-based risk model in European screening settings. Methods: Using four European screening populations in three countries (Italy, Spain, Germany) screened between 2009 and 2020 for women aged 45-69, we performed a nested case-control study to assess the predictive performance of an AI-based risk model. In total, 739 women with incident breast cancers were included together with 7812 controls matched on year of study-entry. Mammographic features (density, microcalcifications, masses, left-right breast asymmetries of these features) were extracted using AI from negative digital mammograms at study-entry. Two-year absolute risks of breast cancer were predicted and assessed after two years of follow-up. Adjusted risk stratification performance metrics were reported per clinical guidelines. Findings: The overall adjusted Area Under the receiver operating characteristic Curve (aAUC) of the AI risk model was 0.72 (95% CI 0.70-0.75) for breast cancers developed in four screening populations. In the 6.2% [529/8551] of women at high risk using the National Institute of Health and Care Excellence (NICE) guidelines thresholds, cancers were more likely diagnosed after 2 years follow-up, risk-ratio (RR) 6.7 (95% CI 5.6-8.0), compared with the 69% [5907/8551] of women classified at general risk by the model. Similar risk-ratios were observed across levels of mammographic density. Interpretation: The AI risk model showed generalizable discriminatory performances across European populations and, predicted â¼30% of clinically relevant stage 2 and higher breast cancers in â¼6% of high-risk women who were sent home with a negative mammogram. Similar results were seen in women with fatty and dense breasts. Funding: Swedish Research Council.
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AIM: The analyses here reported aim to compare the screening performance of digital tomosynthesis (DBT) versus mammography (DM). METHODS: MAITA is a consortium of four Italian trials, REtomo, Proteus, Impeto, and MAITA trial. The trials adopted a two-arm randomised design comparing DBT plus DM (REtomo and Proteus) or synthetic-2D (Impeto and MAITA trial) versus DM; multiple vendors were included. Women aged 45 to 69 years were individually randomised to one round of DBT or DM. FINDINGS: From March 2014 to February 2022, 50,856 and 63,295 women were randomised to the DBT and DM arm, respectively. In the DBT arm, 6656 women were screened with DBT plus synthetic-2D. Recall was higher in the DBT arm (5·84% versus 4·96%), with differences between centres. With DBT, 0·8/1000 (95% CI 0·3 to 1·3) more women received surgical treatment for a benign lesion. The detection rate was 51% higher with DBT, ie. 2·6/1000 (95% CI 1·7 to 3·6) more cancers detected, with a similar relative increase for invasive cancers and ductal carcinoma in situ. The results were similar below and over the age of 50, at first and subsequent rounds, and with DBT plus DM and DBT plus synthetic-2D. No learning curve was appreciable. Detection of cancers >= 20 mm, with 2 or more positive lymph nodes, grade III, HER2-positive, or triple-negative was similar in the two arms. INTERPRETATION: Results from MAITA confirm that DBT is superior to DM for the detection of cancers, with a possible increase in recall rate. DBT performance in screening should be assessed locally while waiting for long-term follow-up results on the impact of advanced cancer incidence.
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Neoplasias da Mama , Carcinoma Intraductal não Infiltrante , Feminino , Humanos , Mama/diagnóstico por imagem , Mama/patologia , Neoplasias da Mama/diagnóstico , Detecção Precoce de Câncer/métodos , Incidência , Mamografia/métodos , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Idoso , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To test the efficacy of self- compared to radiographer-led compression to reduce the average glandular dose without affecting image quality and compliance to follow-up mammography. MATERIALS AND METHODS: Women presenting for mammography for breast cancer follow-up, symptoms, opportunistic screening, or familial risk were asked to participate and, if willing, were randomized to self-compression or radiographer-led compression. Image quality was assessed blindly by two independent radiologists and two radiographers. Pain and discomfort were measured immediately after mammography and their recall was asked when the women participated in the follow-up mammogram, 1 or 2 years later. RESULTS: In total, 495 women (mean age 57 years +/-14) were enrolled, 245 in the self-compression and 250 radiographer-compression arms. Image quality was similar in the two arms (radiologists' judgement p = 0.90; radiographers' judgement p = 0.32). A stronger compression force was reached in the self- than in the radiographer-arm (114.5 vs. 10.25 daN, p < .001), with a 1.7-mm reduction in thickness (p = .14), and almost no impact on dose per exam (1.90 vs. 1.93 mGy, p = .47). Moderate/severe discomfort was reported by 7.8% vs 9.6% (p = .77) and median pain score was 4.0 in both arms (p = .55). Median execution time was 1 min longer with self-compression (10.0 vs. 9.1 min, p < 0.001). No effect on subsequent mammography was detectable (p = 0.47). CONCLUSION: Self-compression achieved stronger compression of the breast, with comparable image quality, but did not substantially reduce glandular dose. The proportion of women who attended follow-up mammography was also similar in the two groups. TRIAL REGISTRATION: clinicaltrials.gov NCT04009278 KEY POINTS: ⢠In mammography, appropriate compression is essential to obtain high image quality and reduce dose. Compression causes pain and discomfort. ⢠Self-compression has been proposed to reach better compression and possibly increase participation in mammography. ⢠In a randomized trial, self-compression reached stronger compression of the breast, with comparable image quality but with no glandular dose reduction or impact on participation in follow-up mammography.
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Neoplasias da Mama , Mamografia , Feminino , Humanos , Pessoa de Meia-Idade , Mamografia/métodos , Mama/diagnóstico por imagem , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/complicações , Pressão , Dor/etiologiaRESUMO
Inflammatory burden is associated with COVID-19 severity and outcomes. Residual computed tomography (CT) lung abnormalities have been reported after COVID-19. The aim was to evaluate the association between inflammatory burden during COVID-19 and residual lung CT abnormalities collected on follow-up CT scans performed 2-3 and 6-7 months after COVID-19, in severe COVID-19 pneumonia survivors. C-reactive protein (CRP) curves describing inflammatory burden during the clinical course were built, and CRP peaks, velocities of increase, and integrals were calculated. Other putative determinants were age, sex, mechanical ventilation, lowest PaO2/FiO2 ratio, D-dimer peak, and length of hospital stay (LOS). Of the 259 included patients (median age 65 years; 30.5% females), 202 (78%) and 100 (38.6%) had residual, predominantly non-fibrotic, abnormalities at 2-3 and 6-7 months, respectively. In age- and sex-adjusted models, best CRP predictors for residual abnormalities were CRP peak (odds ratio [OR] for one standard deviation [SD] increase = 1.79; 95% confidence interval [CI] = 1.23-2.62) at 2-3 months and CRP integral (OR for one SD increase = 2.24; 95%CI = 1.53-3.28) at 6-7 months. Hence, inflammation is associated with short- and medium-term lung damage in COVID-19. Other severity measures, including mechanical ventilation and LOS, but not D-dimer, were mediators of the relationship between CRP and residual abnormalities.
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COVID-19/patologia , Pneumonia/diagnóstico por imagem , Idoso , Proteína C-Reativa/análise , COVID-19/complicações , COVID-19/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Pneumonia/etiologia , Pneumonia/patologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios XRESUMO
Background Adding digital breast tomosynthesis (DBT) to digital mammography (DM) improves breast cancer screening sensitivity, but how this impacts mortality and other end points is unknown. Purpose To compare interval and overall breast cancer incidence after screening with DBT plus DM versus DM alone. Materials and Methods In this prospective trial (RETomo), women attending screening were randomized to one round of DBT plus DM (experimental arm) or to DM (control arm). All were then rescreened with DM after 12 months (women aged 45-49 years) or after 24 months (50-69 years). The primary outcome was interval cancer incidence. Cumulative incidence up to the subsequent screening round plus 9 months (21- and 33-month follow-up for women aged 45-49 and 50-69, respectively) was also reported. Ductal carcinomas in situ are included. Subgroup analyses by age and breast density were conducted; 95% CIs computed according to binomial distribution are reported. Results Baseline cancer detection was higher in the DBT plu DM arm than DM arm (101 of 13 356 women vs 61 of 13 521 women; relative detection, 1.7 [95% CI: 1.2, 2.3]). The mean age ± standard deviation for the women in both arms was 55 years ± 7. Interval cancer incidence was similar in the two arms (21 vs 22 cancers; relative incidence, 0.97 [95% CI: 0.53, 1.8]). Cumulative incidence remained higher in the DBT plus DM arm in women over 50 (153 vs 124 cancers; relative incidence, 1.2 [95% CI: 0.99, 1.6]), while it was similar in the two arms in women aged 45-49 (36 vs 41 cancers; relative incidence, 0.89 [95% CI: 0.57, 1.4]). Conclusion In women younger than 50 years, the benefit of early diagnosis seemed to be appreciable, while for women over age 50, the higher sensitivity of tomosynthesis plus mammography was not matched by a subsequent reduction in cancers at the next screening examination or in the intervening interval. Clinical trial registration no. NCT02698202 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Lee and Ray in this issue.
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Neoplasias da Mama , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , Feminino , Humanos , Incidência , Masculino , Mamografia/métodos , Estudos Prospectivos , Sensibilidade e EspecificidadeRESUMO
We compared accuracy for breast cancer (BC) risk stratification of a new fully automated system (DenSeeMammo-DSM) for breast density (BD) assessment to a non-inferiority threshold based on radiologists' visual assessment. Pooled analysis was performed on 14,267 2D mammograms collected from women aged 48-55 years who underwent BC screening within three studies: RETomo, Florence study and PROCAS. BD was expressed through clinical Breast Imaging Reporting and Data System (BI-RADS) density classification. Women in BI-RADS D category had a 2.6 (95% CI 1.5-4.4) and a 3.6 (95% CI 1.4-9.3) times higher risk of incident and interval cancer, respectively, than women in the two lowest BD categories. The ability of DSM to predict risk of incident cancer was non-inferior to radiologists' visual assessment as both point estimate and lower bound of 95% CI (AUC 0.589; 95% CI 0.580-0.597) were above the predefined visual assessment threshold (AUC 0.571). AUC for interval (AUC 0.631; 95% CI 0.623-0.639) cancers was even higher. BD assessed with new fully automated method is positively associated with BC risk and is not inferior to radiologists' visual assessment. It is an even stronger marker of interval cancer, confirming an appreciable masking effect of BD that reduces mammography sensitivity.
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Densidade da Mama , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/patologia , Processamento de Imagem Assistida por Computador/métodos , Mamografia/métodos , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Software , Adulto , Área Sob a Curva , Automação , Estudos de Casos e Controles , Detecção Precoce de Câncer/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , RiscoRESUMO
OBJECTIVE: The aims of this study were to develop a multiparametric prognostic model for death in COVID-19 patients and to assess the incremental value of CT disease extension over clinical parameters. METHODS: Consecutive patients who presented to all five of the emergency rooms of the Reggio Emilia province between February 27 and March 23, 2020, for suspected COVID-19, underwent chest CT, and had a positive swab within 10 days were included in this retrospective study. Age, sex, comorbidities, days from symptom onset, and laboratory data were retrieved from institutional information systems. CT disease extension was visually graded as < 20%, 20-39%, 40-59%, or ≥ 60%. The association between clinical and CT variables with death was estimated with univariable and multivariable Cox proportional hazards models; model performance was assessed using k-fold cross-validation for the area under the ROC curve (cvAUC). RESULTS: Of the 866 included patients (median age 59.8, women 39.2%), 93 (10.74%) died. Clinical variables significantly associated with death in multivariable model were age, male sex, HDL cholesterol, dementia, heart failure, vascular diseases, time from symptom onset, neutrophils, LDH, and oxygen saturation level. CT disease extension was also independently associated with death (HR = 7.56, 95% CI = 3.49; 16.38 for ≥ 60% extension). cvAUCs were 0.927 (bootstrap bias-corrected 95% CI = 0.899-0.947) for the clinical model and 0.936 (bootstrap bias-corrected 95% CI = 0.912-0.953) when adding CT extension. CONCLUSIONS: A prognostic model based on clinical variables is highly accurate in predicting death in COVID-19 patients. Adding CT disease extension to the model scarcely improves its accuracy. KEY POINTS: ⢠Early identification of COVID-19 patients at higher risk of disease progression and death is crucial; the role of CT scan in defining prognosis is unclear. ⢠A clinical model based on age, sex, comorbidities, days from symptom onset, and laboratory results was highly accurate in predicting death in COVID-19 patients presenting to the emergency room. ⢠Disease extension assessed with CT was independently associated with death when added to the model but did not produce a valuable increase in accuracy.
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COVID-19 , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , SARS-CoV-2 , Tomografia Computadorizada por Raios XRESUMO
OBJECTIVE: To assess sensitivity/specificity of CT vs RT-PCR for the diagnosis of COVID-19 pneumonia in a prospective Italian cohort of symptomatic patients during the outbreak peak. METHODS: In this cross-sectional study, we included all consecutive patients who presented to the ER between March 13 and 23 for suspected COVID-19 and underwent CT and RT-PCR within 3 days. Using a structured report, radiologists prospectively classified CTs in highly suggestive, suggestive, and non-suggestive of COVID-19 pneumonia. Ground-glass, consolidation, and visual extension of parenchymal changes were collected. Three different RT-PCR-based reference standard definitions were used. Oxygen saturation level, CRP, LDH, and blood cell counts were collected and compared between CT/RT-PCR classes. RESULTS: The study included 696 patients (41.4% women; age 59 ± 15.8 years): 423/454 (93%) patients with highly suggestive CT, 97/127 (76%) with suggestive CT, and 31/115 (27%) with non-suggestive CT had positive RT-PCR. CT sensitivity ranged from 73 to 77% and from 90 to 94% for high and low positivity threshold, respectively. Specificity ranged from 79 to 84% for high positivity threshold and was about 58% for low positivity threshold. PPV remained ≥ 90% in all cases. Ground-glass was more frequent in patients with positive RT-PCR in all CT classes. Blood tests were significantly associated with RT-PCR and CT classes. Leukocytes, lymphocytes, neutrophils, and platelets decreased, CRP and LDH increased from non-suggestive to suggestive CT classes. CONCLUSIONS: During the outbreak peak (in a high-prevalence setting), CT presented high PPV and may be considered a good reference to recognize COVID-19 patients while waiting for RT-PCR confirmation. KEY POINTS: ⢠During the epidemic peak, CT showed high positive predictive value and sensitivity for COVID-19 pneumonia when compared with RT-PCR. ⢠Blood tests were significantly associated with RT-PCR and CT classes.
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Betacoronavirus , Infecções por Coronavirus/diagnóstico , Pandemias , Pneumonia Viral/diagnóstico , Tomografia Computadorizada por Raios X/métodos , COVID-19 , Infecções por Coronavirus/epidemiologia , Estudos Transversais , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Pneumonia Viral/epidemiologia , Estudos Prospectivos , Reprodutibilidade dos Testes , SARS-CoV-2RESUMO
The aim of the study is to use the well-known channelized Hotelling observer model (CHO) to characterize a recently installed angiography system (GE Discovery IGS 740) using sets of images of a contrast-detail phantom acquired with clinical protocols. A Leeds TO10 phantom was used. The phantom has 108 details: 12 diameters (size range: 0.25 mm-11 mm), each with nine contrasts (declared range: 0.012-0.930 at 70 kVp 1.00 with 1 mm Cu filtration). TO10 has been imaged between two 10 cm thick homogeneous solid water slabs. Two FOVs (32 cm and 20 cm) were used. Fluoroscopy images were taken using an abdominal protocol at two different frame rates (15 fps and 7.5 fps) and at two dose levels (low and normal); cineangiography images were acquired using an abdominal protocol at 15 fps at two dose levels (low and normal). A 40 Gabor channels CHO with internal noise was used. Human observers' studies were carried out to tune the internal noise parameter and to validate the model observer. Contrast-detail curves were obtained from the CHO output using a visibility threshold of 75% and fitted with Rose's model theory in order to characterize the angiography system. Wilcoxon rank-sum tests were performed to investigate possible differences among the different sets of images. The CHO can distinguish between the two dose levels (pâ-values < 0.002), while FOV and frame rate do not affect the contrast-detail curves significantly. It is important to note that the CHO does not find statistically significant differences between a fluoroscopy with FOV = 20 cm at normal dose level (17.6 mGy min-1) and a cineangiography with FOV = 32 cm low dose level (42.1 mGy min-1). This result can lead to a dose reduction of about 70% for our specific task (i.e. a static, disc shaped object at known location in homogeneous field). Given their stability in comparison to human observers, model observers provide an effective tool for image quality evaluation.
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Angiografia/instrumentação , Processamento de Imagem Assistida por Computador , Imagens de Fantasmas , Humanos , Variações Dependentes do ObservadorRESUMO
OBJECTIVES: Tomosynthesis (DBT) has proven to be more sensitive than digital mammography, but it requires longer reading time. We retrospectively compared accuracy and reading times of a simplified protocol with 1-cm-thick slabs versus a standard protocol of slabs + 1-mm-spaced planes, both integrated with synthetic 2D. METHODS: We randomly selected 894 DBTs (including 12 cancers) from the experimental arm of the RETomo trial. DBTs were read by two radiologists to estimate specificity. A second set of 24 cancers (8 also present in the first set) mixed within 276 negative DBTs was read by two radiologists. In total, 28 cancers with 64 readings were used to estimate sensitivity. Radiologists read with both protocols separated by a 3-month washout. Only women that were positive at the screening reading were assessed. Variance was estimated taking into account repeated measures. RESULTS: Sensitivity was 82.8% (53/64, 95% confidence interval (95% CI) 67.2-92.2) and 90.6% (95% CI 80.2-95.8) with simplified and standard protocols, respectively. In the random screening setting, specificity was 97.9% (1727/1764, 95% CI 97.1-98.5) and 96.3% (95% CI 95.3-97.1), respectively. Inter-reader agreement was 0.68 and 0.54 with simplified and standard protocols, respectively. Median reading times with simplified protocol were 20% to 30% shorter than with standard protocol. CONCLUSIONS: A simplified protocol reduced reading time and false positives but may have a negative impact on sensitivity. KEY POINTS: ⢠The adoption of digital breast tomosynthesis (DBT) in screening, more sensitive than mammography, could be limited by its potential effect on the radiologists' workload, i.e., increased reading time and fatigue. ⢠A DBT simplified protocol with slab only, compared to a standard protocol (slab plus planes) both integrated with synthetic 2D, reduced time and false positives but had a negative impact on sensitivity.
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Neoplasias da Mama/diagnóstico , Carcinoma Intraductal não Infiltrante/diagnóstico , Detecção Precoce de Câncer/métodos , Mamografia/métodos , Programas de Rastreamento/métodos , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Estudos RetrospectivosRESUMO
PURPOSE: The aim of this study was to propose and validate across various clinical scanner systems a straightforward multiparametric quality assurance procedure for proton magnetic resonance spectroscopy (MRS). METHODS: Eighteen clinical 1.5â¯T and 3â¯T scanner systems for MRS, from 16 centres and 3 different manufacturers, were enrolled in the study. A standard spherical water phantom was employed by all centres. The acquisition protocol included 3 sets of single (isotropic) voxel (size 20â¯mm) PRESS acquisitions with unsuppressed water signal and acquisition voxel position at isocenter as well as off-center, repeated 4/5 times within approximately 2â¯months. Water peak linewidth (LW) and area under the water peak (AP) were estimated. RESULTS: LW values [mean (standard deviation)] were 1.4 (1.0)â¯Hz and 0.8 (0.3)â¯Hz for 3â¯T and 1.5â¯T scanners, respectively. The mean (standard deviation) (across all scanners) coefficient of variation of LW and AP for different spatial positions of acquisition voxel were 43% (20%) and 11% (11%), respectively. The mean (standard deviation) phantom T2values were 1145 (50) ms and 1010 (95) ms for 1.5â¯T and 3â¯T scanners, respectively. The mean (standard deviation) (across all scanners) coefficients of variation for repeated measurements of LW, AP and T2 were 25% (20%), 10% (14%) and 5% (2%), respectively. CONCLUSIONS: We proposed a straightforward multiparametric and not time consuming quality control protocol for MRS, which can be included in routine and periodic quality assurance procedures. The protocol has been validated and proven to be feasible in a multicentre comparison study of a fairly large number of clinical 1.5â¯T and 3â¯T scanner systems.
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Espectroscopia de Prótons por Ressonância Magnética/normas , Imagens de Fantasmas , Controle de QualidadeRESUMO
Purpose To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. Materials and Methods For this trial, eligible women (45-70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). Women were treated according to the decision at DBT+DM. Sensitivity, recall rate, and positive predictive value (PPV) at baseline were determined; the ratios of these rates for DBT+DM relative to DM alone were determined. Results From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5% in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89%; 95% confidence interval [CI]: 31, 72). PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; -12 [95% CI: -68, 141]; for invasive cancers < 10 mm, 10-19 mm, and ≥ 20 mm, respectively). Conclusion DBT+DM depicts 90% more cancers in a population previously screened with DM, with similar recall rates.
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Neoplasias da Mama/diagnóstico por imagem , Detecção Precoce de Câncer/métodos , Mamografia/métodos , Programas de Rastreamento/métodos , Intensificação de Imagem Radiográfica/métodos , Idoso , Mama/diagnóstico por imagem , Feminino , Humanos , Itália , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Neoadjuvant-chemotherapy (NAC) is considered the standard treatment for locally advanced breast carcinomas. Accurate assessment of disease response is fundamental to increase the chances of successful breast-conserving surgery and to avoid local recurrence. The purpose of this study was to compare contrast-enhanced spectral mammography (CESM) and contrast-enhanced-MRI (MRI) in the evaluation of tumor response to NAC. METHODS: This prospective study was approved by the institutional review board and written informed consent was obtained. Fifty-four consenting women with breast cancer and indication of NAC were consecutively enrolled between October 2012 and December 2014. Patients underwent both CESM and MRI before, during and after NAC. MRI was performed first, followed by CESM within 3 days. Response to therapy was evaluated for each patient, comparing the size of the residual lesion measured on CESM and MRI performed after NAC to the pathological response on surgical specimens (gold standard), independently of and blinded to the results of the other test. The agreement between measurements was evaluated using Lin's coefficient. The agreement between measurements using CESM and MRI was tested at each step of the study, before, during and after NAC. And last of all, the variation in the largest dimension of the tumor on CESM and MRI was assessed according to the parameters set in RECIST 1.1 criteria, focusing on pathological complete response (pCR). RESULTS: A total of 46 patients (85%) completed the study. CESM predicted pCR better than MRI (Lin's coefficient 0.81 and 0.59, respectively). Both methods tend to underestimate the real extent of residual tumor (mean 4.1mm in CESM, 7.5mm in MRI). The agreement between measurements using CESM and MRI was 0.96, 0.94 and 0.76 before, during and after NAC respectively. The distinction between responders and non-responders with CESM and MRI was identical for 45/46 patients. In the assessment of CR, sensitivity and specificity were 100% and 84%, respectively, for CESM, and 87% and 60% for MRI. CONCLUSION: CESM and MRI lesion size measurements were highly correlated. CESM seems at least as reliable as MRI in assessing the response to NAC, and may be an alternative if MRI is contraindicated or its availability is limited.
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Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/tratamento farmacológico , Mama/diagnóstico por imagem , Terapia Neoadjuvante , Adulto , Idoso , Mama/efeitos dos fármacos , Mama/patologia , Neoplasias da Mama/patologia , Meios de Contraste/uso terapêutico , Feminino , Humanos , Imageamento por Ressonância Magnética/métodos , Mamografia/métodos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/diagnóstico por imagem , Recidiva Local de Neoplasia/tratamento farmacológico , Recidiva Local de Neoplasia/patologia , Estudos Prospectivos , Resultado do TratamentoRESUMO
In 2012, the Reggio Emilia Breast Cancer Screening Program introduced digital mammography in all its facilities at the same time. The aim of this work is to analyze the impact of digital mammography introduction on the recall rate, detection rate, and positive predictive value. The program actively invites women aged 45-74 years. We included women screened in 2011, all of whom underwent film-screen mammography, and all women screened in 2012, all of whom underwent digital mammography. Double reading was used for all mammograms, with arbitration in the event of disagreement. A total of 42,240 women underwent screen-film mammography and 45,196 underwent digital mammography. The recall rate increased from 3.3 to 4.4% in the first year of digital mammography (relative recall adjusted by age and round 1.46, 95% CI = 1.37-1.56); the positivity rate for each individual reading, before arbitration, rose from 3 to 5.7%. The digital mammography recall rate decreased during 2012: after 12 months, it was similar to the recall rate with screen-film mammography. The detection rate was similar: 5.9/1000 and 5.2/1000 with screen-film and digital mammography, respectively (adjusted relative detection rate 0.95, 95% CI = 0.79-1.13). The relative detection rate for ductal carcinoma in situ remained the same. The introduction of digital mammography to our organized screening program had a negative impact on specificity, thereby increasing the recall rate. The effect was limited to the first 12 months after introduction and was attenuated by the double reading with arbitration. We did not observe any relevant effects on the detection rate.
Assuntos
Neoplasias da Mama/diagnóstico por imagem , Mamografia/estatística & dados numéricos , Programas de Rastreamento/estatística & dados numéricos , Reações Falso-Negativas , Reações Falso-Positivas , Feminino , Humanos , Mamografia/tendências , Programas de Rastreamento/normasRESUMO
PURPOSE: Clinical risk management is the basis of safety procedures also in radiological workflows. In the literature, it has been documented that the incidence of reconciled radiological studies ranges between 0.2 and 0.5 % of stored studies, a non-negligible value if we consider the high number of diagnostic tests performed. MATERIALS AND METHODS: In radiology, "non-compliance" or, more generally, data to be reconciled means any circumstance in which wrong information is recorded in RIS and/or PACS, which requires processing to amend or correct images, reports or other information in order to attribute them to the right patient/episode. Non-compliance corrections account for almost 50 % of the medical system administrator's (SA) workload. This paper describes how the Reggio Emilia Province Diagnostic Imaging and Laboratory Medicine Department manages risk in clinical radiology, in compliance with Regional indications on RIS-PACS safety. A dedicated RIS webpage has been developed in order to manage reconciliation requests. Native integration with PACS makes information about ongoing reconciliations available to anyone who consults the images. RESULTS: In 2013, non-compliances reported by radiology staff ranged between 0.25 and 0.35 % of studies sent to the PACS. More than 50 % of non-compliances can be related to high clinical risk, which requires implementation of efficient and effective rapid mechanisms of action-reaction inside and outside the radiology department. CONCLUSIONS: The RIS-integrated module has been the starting point for managing and monitoring errors, allowing improvement initiatives to guarantee and optimise workflow. Request and event traceability have allowed us to define personalised training programmes, designed to minimise procedural and/or systematic errors. To protect the availability and consistency of information produced by radiology units, it is necessary to provide integrated and effective mechanisms for reconciliation management. The integrated tool described in this paper is now widely used (not only by our centre): radiographers and radiologists can indicate non-compliances in an efficient and effective manner, informing all the operators involved with just a click of the mouse. Similar functionality should be implemented in the next generation of RIS-PACS in order to maintain the highest possible safety level for patients and workers.
Assuntos
Segurança do Paciente , Sistemas de Informação em Radiologia , Gestão de Riscos/métodos , Computadores , Humanos , Serviço Hospitalar de RadiologiaRESUMO
PURPOSE: A characterization of a clinical unit for digital radiography (FUJIFILM FDR D-EVO) is presented. This system is based on the irradiation side sampling (ISS) technology and can be equipped with two different scintillators: one traditional gadolinium-oxysulphide phosphor (GOS) and a needle structured cesium iodide (CsI) phosphor panel. METHODS: The characterization was achieved in terms of response curve, modulation transfer function (MTF), noise power spectra (NPS), detective quantum efficiency (DQE), and psychophysical parameters (contrast-detail analysis with an automatic reading of CDRAD images). For both scintillation screens the authors accomplished the measurements with four standard beam conditions: RAQ3, RQA5, RQA7, and RQA9. RESULTS: At the Nyquist frequency (3.33 lp/mm) the MTF is about 35% and 25% for CsI and GOS detectors, respectively. The CsI scintillator has better noise properties than the GOS screen in almost all the conditions. This is particularly true for low-energy beams, where the noise for the GOS system can go up to a factor 2 greater than that found for CsI. The DQE of the CsI detector reaches a peak of 60%, 60%, 58%, and 50% for the RQA3, RQA5, RQA7, and RQA9 beams, respectively, whereas for the GOS screen the maximum DQE is 40%, 44%, 44%, and 35%. The contrast-detail analysis confirms that in the majority of cases the CsI scintillator is able to provide improved outcomes to those obtained with the GOS screen. CONCLUSIONS: The limited diffusion of light produced by the ISS reading makes possible the achievement of very good spatial resolution. In fact, the MTF of the unit with the CsI panel is only slightly lower to that achieved with direct conversion detectors. The combination of very good spatial resolution, together with the good noise properties reached with the CsI screen, allows achieving DQE on average about 1.5 times greater than that obtained with GOS. In fact, the DQE of unit equipped with CsI is comparable to the best alternative methods available which are based on the same technology, and similar to others based on an a-Se direct conversion detectors.
Assuntos
Intensificação de Imagem Radiográfica/métodos , Césio/química , Gadolínio/química , Humanos , Iodetos/química , Sulfetos/químicaRESUMO
In RIS-PACS systems, potential errors occurring during the execution of a radiologic examination can amplify the clinical risks of the patient during subsequent treatments, e.g., of oncologic patients or of those who must do additional treatments based on the initial diagnosis. In Reggio Emilia Province Diagnostic Imaging Department (REDID) we experienced different strategies to reduce clinical risks due to patient reconciliation errors. In 2010, we developed a procedure directly integrated in our RIS-PACS that uses Health Level 7 (HL7) standard messaging, which generates an overlay with the text "under investigation" on the images of the study to be corrected. All the healthcare staff is informed of the meaning of that overlay, and only the radiologist and the emergency services staff can consult these images on PACS. The elimination of image overlay and of any access limitation to PACS was triggered to confirm of the right correction made by RIS-PACS system administrator (SA). The RIS-PACS integrated tool described in this paper allows technologists and radiologists to efficiently highlight patient exam errors and to inform all the users to minimize the overall clinical risks, with a significant savings in costs. Over the years, we have observed a steady decrease in the percentage of reconciled studies. Error reconciliation requires an effective and efficient mechanism. The RIS-PACS integrated tool described in this paper enables technologists and radiologists to quickly and efficiently highlight patient exam errors and inform all the users. Next generation of RIS-PACS could be equipped with similar reconciliation tools.
Assuntos
Erros de Diagnóstico/prevenção & controle , Nível Sete de Saúde , Garantia da Qualidade dos Cuidados de Saúde , Sistemas de Informação em Radiologia/organização & administração , Difusão de Inovações , Eficiência Organizacional , Humanos , RiscoRESUMO
PURPOSE: The purpose of this study is to compare digital radiography systems using the metric effective detective quantum efficiency (eDQE), which better reflects digital radiography imaging system performance under clinical operating conditions, in comparison with conventional metrics such as modulation transfer function (MTF), normalized noise power spectra (NNPS), and detective quantum efficiency (DQE). METHODS: The eDQE was computed by the calculation of the MTF, the NNPS, the phantom attenuation and scatter, and estimation of x-ray flux. The physical characterization of the systems was obtained with the standard beam conditions RQA5 and RQA9, using the PA Chest phantom proposed by AAPM Report # 31 simulating the attenuation and scatter characteristics of the adult human thorax. The MTF (eMTF) was measured by using an edge test placed at the frontal surface of the phantom, the NNPS (eNNPS) was calculated from images of the phantom acquired at three different exposure levels covering the operating range of the system (E(0), which is the exposure at which a system is normally operated, 1/3 E(0), and 3 E0), and scatter measurements were assessed by using a beam-stop technique. The integral of DQE (IDQE) and eDQE (IeDQE) was calculated over the whole spatial frequency range. RESULTS: The eMTF results demonstrate degradation due to magnification and the presence of scattered radiation. The eNNPS was influenced by the grid presence, and in some systems, it contained structured noise. At typical clinical exposure levels, the magnitude of eDQE(0) with respect to DQE(0) at RQA9 beam conditions was 13%, 17%, 16%, 36%, and 24%, respectively, for Carestream DRX-1, Carestream DRX-1C, Carestream Direct View CR975, Philips Digital Diagnost VM, and GE Revolution XR/d. These results were confirmed by the ratio of IeDQE and IDQE in the same conditions. CONCLUSIONS: The authors confirm the robustness and reproducibility of the eDQE method. As expected, the DR systems performed better than the CR systems due to their superior signal-to-noise transfer characteristics. The results of this study suggest the eDQE method may provide an opportunity to more accurately assess the clinical performance of digital radiographic imaging systems by accounting for factors such as the presence of scatter, use of an antiscatter grid, and magnification and focal spot blurring effects, which are not reflected in conventional DQE measures.