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Abstract Objective: To demonstrate that positive predictive values (PPVs) for suspicious (category 4) magnetic resonance imaging (MRI) findings that have been stratified are equivalent to those stipulated in the American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) for mammography and ultrasound. Materials and Methods: This retrospective analysis of electronic medical records generated between January 4, 2016 and December 29, 2021 provided 365 patients in which 419 suspicious (BI-RADS category 4) findings were subcategorized as BI-RADS 4A, 4B or 4C. Malignant and nonmalignant outcomes were determined by pathologic analyses, follow-up, or both. For each subcategory, the level 2 PPV (PPV2) was calculated and tested for equivalence/noninferiority against the established benchmarks. Results: Of the 419 findings evaluated, 168 (40.1%) were categorized as malignant and 251 (59.9%) were categorized as nonmalignant. The PPV2 for subcategory 4A was 14.2% (95% CI: 9.3-20.4%), whereas it was 41.2% (95% CI: 32.8-49.9%) for subcategory 4B and 77.2% (95% CI: 68.4-84.5%) for subcategory 4C. Multivariate analysis showed a significantly different cancer yield for each subcategory (p < 0.001). Conclusion: We found that stratification of suspicious findings by MRI criteria is feasible, and malignancy probabilities for sub-categories 4B and 4C are equivalent to the values established for the other imaging methods in the BI-RADS. Nevertheless, low suspicion (4A) findings might show slightly higher malignancy rates.
Resumo Objetivo: Demonstrar que os valores preditivos positivos (VPPs) para lesões suspeitas (categoria 4) identificadas por ressonância magnética (RM) são equivalentes aos estipulados no ACR BI-RADS para mamografia e ultrassonografia. Materiais e Métodos: Análise retrospectiva de dados em prontuário eletrônico, entre 4 de janeiro de 2016 e 29 de dezembro de 2021, resultou em 365 pacientes elegíveis, com 419 lesões classificadas como BI-RADS 4A, 4B ou 4C. Desfechos malignos e não malignos foram determinados por estudo patológico e/ou acompanhamento. Realizamos o cálculo do VPP nível 2 (VPP2) para cada subcategoria e testamos para não inferioridade/equivalência em relação aos valores de referência. Resultados: Dos 419 achados, 168 (40,1%) foram malignos e 251 (59,9%), não malignos. O VPP2 para subcategoria 4A foi 14,2% (IC 95%: 9,3-20,4%), para 4B foi 41,2% (IC 95%:, 32,8-49,9%) e para 4C foi 77,2% (IC 95%: 68,4-84,5%). Análise multivariada demonstrou diferenças estatisticamente significantes entre as subcategorias (p < 0,001). Conclusão: A estratificação de achados suspeitos por RM é factível, sendo que a probabilidade de malignidade das subcategorias 4B e 4C é equivalente à estabelecida para outros métodos de imagem pelo BI-RADS. Contudo, lesões de baixa suspeição (4A) podem apresentar taxas mais altas de malignidade.
RESUMEN
Objective: To demonstrate that positive predictive values (PPVs) for suspicious (category 4) magnetic resonance imaging (MRI) findings that have been stratified are equivalent to those stipulated in the American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) for mammography and ultrasound. Materials and Methods: This retrospective analysis of electronic medical records generated between January 4, 2016 and December 29, 2021 provided 365 patients in which 419 suspicious (BI-RADS category 4) findings were subcategorized as BI-RADS 4A, 4B or 4C. Malignant and nonmalignant outcomes were determined by pathologic analyses, follow-up, or both. For each subcategory, the level 2 PPV (PPV2) was calculated and tested for equivalence/noninferiority against the established benchmarks. Results: Of the 419 findings evaluated, 168 (40.1%) were categorized as malignant and 251 (59.9%) were categorized as nonmalignant. The PPV2 for subcategory 4A was 14.2% (95% CI: 9.3-20.4%), whereas it was 41.2% (95% CI: 32.8-49.9%) for subcategory 4B and 77.2% (95% CI: 68.4-84.5%) for subcategory 4C. Multivariate analysis showed a significantly different cancer yield for each subcategory (p < 0.001). Conclusion: We found that stratification of suspicious findings by MRI criteria is feasible, and malignancy probabilities for sub-categories 4B and 4C are equivalent to the values established for the other imaging methods in the BI-RADS. Nevertheless, low suspicion (4A) findings might show slightly higher malignancy rates.
Objetivo: Demonstrar que os valores preditivos positivos (VPPs) para lesões suspeitas (categoria 4) identificadas por ressonância magnética (RM) são equivalentes aos estipulados no ACR BI-RADS para mamografia e ultrassonografia. Materiais e Métodos: Análise retrospectiva de dados em prontuário eletrônico, entre 4 de janeiro de 2016 e 29 de dezembro de 2021, resultou em 365 pacientes elegíveis, com 419 lesões classificadas como BI-RADS 4A, 4B ou 4C. Desfechos malignos e não malignos foram determinados por estudo patológico e/ou acompanhamento. Realizamos o cálculo do VPP nível 2 (VPP2) para cada subcategoria e testamos para não inferioridade/equivalência em relação aos valores de referência. Resultados: Dos 419 achados, 168 (40,1%) foram malignos e 251 (59,9%), não malignos. O VPP2 para subcategoria 4A foi 14,2% (IC 95%: 9,320,4%), para 4B foi 41,2% (IC 95%:, 32,849,9%) e para 4C foi 77,2% (IC 95%: 68,484,5%). Análise multivariada demonstrou diferenças estatisticamente significantes entre as subcategorias (p < 0,001). Conclusão: A estratificação de achados suspeitos por RM é factível, sendo que a probabilidade de malignidade das subcategorias 4B e 4C é equivalente à estabelecida para outros métodos de imagem pelo BI-RADS. Contudo, lesões de baixa suspeição (4A) podem apresentar taxas mais altas de malignidade.
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OBJECTIVE: To test the use of diffusion-weighted imaging (DWI) in stratifying suspicious breast lesions (BI-RADS 4), correlating them with histopathology. We also investigated the performance of DWI related to the main enhancement patterns (mass and non-mass) and tested its reproducibility. MATERIALS AND METHODS: Seventy-six patients presented 92 lesions during the sampling period. Two independent examiners reviewed magnetic resonance imaging studies, described the lesions, and determined the apparent diffusion coefficient (ADC) values. Differences among benign, indeterminate- to high-risk, and malignant findings, in terms of the ADCs, were assessed by analysis of variance. Using receiver operating characteristic (ROC) curves, we compared the performance of ADC values in masses and non-mass lesions, and tested the reproducibility of measurements by determining the coefficient of variation and smallest real difference. RESULTS: Among the 92 lesions evaluated, the histopathology showed that 37 were benign, 11 were indeterminate- to high-risk, and 44 were malignant. The mean ADC differed significantly among those histopathological groups, the value obtained for the malignant lesions (1.10 × 10-3 mm2/s) being significantly lower than that obtained for the other groups (p < 0.001). ROC curves demonstrated that DWI performed better when applied to masses than when applied to non-mass lesions (area under the curve, 0.88 vs. 0.67). Reproducibility was good (coefficient of variation, 7.03%; and smallest real difference, ± 0.242 × 10-3 mm2/s). CONCLUSION: DWI can differentiate between malignant and nonmalignant (benign or indeterminate- to high-risk) lesions, showing better performance for masses. Nevertheless, stratification based on histopathological criteria that are more refined has yet to be achieved.
OBJETIVO: Testar a sequência ponderada em difusão (SPD) para estratificação de lesões suspeitas (BI-RADS 4) por ressonância magnética em correlação com a histopatologia. Também investigamos o desempenho da SPD relacionada a padrões de realce (nódulo e não nódulo) e testamos sua reprodutibilidade. MATERIAIS E MÉTODOS: Setenta e seis pacientes apresentaram 92 lesões durante o período amostral. Dois examinadores independentes revisaram os estudos, descreveram as lesões e mediram os coeficientes de difusão aparente (CDAs). Diferenças de CDA entre achados benignos, indeterminados/de alto risco e malignos foram avaliadas por análise de variância. Comparamos o desempenho dos CDAs em nódulos e não nódulos por curvas receiver operating characteristic (ROC) e testamos a reprodutibilidade das mensurações pelo coeficiente de variação e menor diferença real. RESULTADOS: Obtivemos 37 lesões benignas, 11 indeterminadas/de alto-risco e 44 cânceres. As médias dos CDAs desses grupos histopatológicos foram significativamente diferentes (p < 0,001), devido aos valores mais baixos em achados malignos (1,10 × 10-3 mm2/s). Curvas ROC demonstraram melhor desempenho da SPD aplicada a nódulos (área sob a curva de 0,88 contra 0,67 para não nódulos). A reprodutibilidade foi boa (coeficiente de variação de 7,03% e menor diferença real de ± 0,242 × 10-3 mm2/s). CONCLUSÃO: A SPD pode diferenciar achados malignos de não malignos, com melhor desempenho para nódulos. Entretanto, a estratificação baseada em critérios histopatológicos mais refinados ainda não foi alcançada.
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Abstract Objective: To test the use of diffusion-weighted imaging (DWI) in stratifying suspicious breast lesions (BI-RADS 4), correlating them with histopathology. We also investigated the performance of DWI related to the main enhancement patterns (mass and non-mass) and tested its reproducibility. Materials and Methods: Seventy-six patients presented 92 lesions during the sampling period. Two independent examiners reviewed magnetic resonance imaging studies, described the lesions, and determined the apparent diffusion coefficient (ADC) values. Differences among benign, indeterminate- to high-risk, and malignant findings, in terms of the ADCs, were assessed by analysis of variance. Using receiver operating characteristic (ROC) curves, we compared the performance of ADC values in masses and non-mass lesions, and tested the reproducibility of measurements by determining the coefficient of variation and smallest real difference. Results: Among the 92 lesions evaluated, the histopathology showed that 37 were benign, 11 were indeterminate- to high-risk, and 44 were malignant. The mean ADC differed significantly among those histopathological groups, the value obtained for the malignant lesions (1.10 × 10-3 mm2/s) being significantly lower than that obtained for the other groups (p < 0.001). ROC curves demonstrated that DWI performed better when applied to masses than when applied to non-mass lesions (area under the curve, 0.88 vs. 0.67). Reproducibility was good (coefficient of variation, 7.03%; and smallest real difference, ± 0.242 × 10-3 mm2/s). Conclusion: DWI can differentiate between malignant and nonmalignant (benign or indeterminate- to high-risk) lesions, showing better performance for masses. Nevertheless, stratification based on histopathological criteria that are more refined has yet to be achieved.
Resumo Objetivo: Testar a sequência ponderada em difusão (SPD) para estratificação de lesões suspeitas (BI-RADS 4) por ressonância magnética em correlação com a histopatologia. Também investigamos o desempenho da SPD relacionada a padrões de realce (nódulo e não nódulo) e testamos sua reprodutibilidade. Materiais e Métodos: Setenta e seis pacientes apresentaram 92 lesões durante o período amostral. Dois examinadores independentes revisaram os estudos, descreveram as lesões e mediram os coeficientes de difusão aparente (CDAs). Diferenças de CDA entre achados benignos, indeterminados/de alto risco e malignos foram avaliadas por análise de variância. Comparamos o desempenho dos CDAs em nódulos e não nódulos por curvas receiver operating characteristic (ROC) e testamos a reprodutibilidade das mensurações pelo coeficiente de variação e menor diferença real. Resultados: Obtivemos 37 lesões benignas, 11 indeterminadas/de alto-risco e 44 cânceres. As médias dos CDAs desses grupos histopatológicos foram significativamente diferentes (p < 0,001), devido aos valores mais baixos em achados malignos (1,10 × 10-3 mm2/s). Curvas ROC demonstraram melhor desempenho da SPD aplicada a nódulos (área sob a curva de 0,88 contra 0,67 para não nódulos). A reprodutibilidade foi boa (coeficiente de variação de 7,03% e menor diferença real de ± 0,242 × 10-3 mm2/s). Conclusão: A SPD pode diferenciar achados malignos de não malignos, com melhor desempenho para nódulos. Entretanto, a estratificação baseada em critérios histopatológicos mais refinados ainda não foi alcançada.
RESUMEN
Objective: To investigate if apparent diffusion coefficient (ADC) values can discriminate ductal carcinomas in situ (DCIS) from invasive carcinomas and to test the incremental gain of a model combining these measurements to dynamic contrast-enhanced (DCE) main pattern (mass versus non-mass). Methods: Forty-four lesions (12 DCIS and 32 invasive cancers) were reviewed by two examiners, their ADCs were averaged, and they were classified according to enhancement patterns. A logistic regression model with ADC values and enhancement patterns was devised. Receiver operating characteristic (ROC) curves were used to compare the discriminative performance of isolated ADCs to the regression model by their areas under the curve (AUCs). Results: ADC values were significantly different between lesion types (p=0.034), with mean of 1.23x10-3 mm2/s for DCIS and 1.05x10-3 mm2 /s for invasive cancers. The model grouping enhancement patterns and ADC values had better performance AUC=0.80) than isolated ADCs (AUC=0.71), though the difference was not statistically significant (p=0.105). Conclusion: ADC measurements of pre-invasive breast lesions are substantially different from those of invasive cancers. When ADC measurements are associated with main enhancement patterns, the performance of the technique is increased.
Objetivo: Investigar se valores de coeficiente de difusão aparente (ADC) podem discriminar carcinomas ductais in situ (CDIS) de carcinomas invasivos e testar o ganho incremental de modelo combinando tais medidas ao padrão principal de realce (nódulo versus realce não nodular) do estudo contrastado dinâmico (ECD). Métodos: Quarenta e quatro lesões (12 CDIS e 32 cânceres invasivos) foram revisadas por dois examinadores, seus ADCs médios calculados e elas foram classificadas de acordo com padrões de realce. Um modelo de regressão logística com valores de ADC e padrões de realce foi delineado. Curvas receiver operating characteristic (ROC) foram utilizadas para comparar a performance discriminativa dos ADCs isolados ao modelo de regressão através de suas áreas sob a curva (AUCs). Resultados: Os valores de ADC foram significantemente diferentes entre tipos de lesão (p=0,034), com média de 1,23x10-3 mm2 /s para CDIS e 1,05x10-3 mm2 /s para cânceres invasivos. O modelo agrupando padrões de realce e valores de ADC teve melhor performance (AUC=0,80) do que ADCs isolados (AUC=0,71), ainda que a diferença não tenha sido estatisticamente significante (p=0,105). Conclusão: Medidas de ADC de lesões mamárias pré-invasivas são substancialmente diferentes daquelas de cânceres invasivos. Quando medidas de ADC são associadas aos principais padrões de realce, a performance da técnica é aumentada.
RESUMEN
OBJECTIVE: The purposes of this study were to investigate whether dynamic contrast-enhanced MRI is adequate for subcategorization of suspicious lesions (BI-RADS category 4) and to evaluate whether use of DWI improves diagnostic performance. MATERIALS AND METHODS: The study group was composed of 103 suspicious lesions found in 83 subjects. Patient ages and lesion sizes were compiled, and two radiologists reanalyzed the images; subcategorized the findings as BI-RADS 4A, 4B, or 4C; and calculated apparent diffusion coefficient (ADC) values. The stratified variables were tested by univariate analysis and inserted in two multivariate predictive models, which were used to generate ROC curves and compare AUCs. Positive predictive values (PPVs) for each subcategory and ADC level were calculated, and interobserver agreement was tested. RESULTS: Forty-four (42.7%) suspicious findings proved malignant. Except for age (p = 0.08), all stratified predictor variables were significant in univariate analyses (p < 0.01). Logistic regression models did not differ substantially after comparison of the ROC curves (p = 0.09), but the one including ADC values was slightly better: AUC of 0.89 (95% CI, 0.82-0.95) against AUC of 0.85 (95% CI, 0.78-0.93). PPV increased progressively in each BI-RADS 4 subcategory (4A, 0.15; 4B, 0.37; 4C, 0.84). ADC values of 1.10 × 10(-3) mm(2)/s or less had the second highest PPV (0.77). Interobserver agreement was substantial at a kappa value of 0.80 (95% CI, 0.70-0.90; p < 0.01). CONCLUSION: Risk stratification of suspicious lesions (BI-RADS category 4) can be satisfactorily performed with DCE-MRI and slightly improved when DWI is introduced.