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Prevalence and Predictive Value of BI-RADS 3, 4, and 5 Lesions Detected on Breast MRI

Rationale and Objectives

This study aims to determine the prevalence and predictive value of Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 findings on breast magnetic resonance imaging (MRI) and to evaluate the impact of study indication on the predictive value of BI-RADS categories.

Materials and Methods

This institutional review board approved, Health Insurance Portability and Accountability Act (HIPAA) compliant retrospective review of our breast MRI database from 2009 to 2011, of 5778 contrast-enhanced studies in 3360 patients was performed. At our institution, each breast receives an individual BI-RADS assessment. Breast MRI reports and electronic medical records were reviewed to obtain BI-RADS assessment, patient demographics, and outcomes. Univariate analysis was performed with Fisher exact and chi-square tests.

Results

A total of 9216 BI-RADS assessments were assigned during the study period: 7879 (85.5%) BI-RADS 1 and 2, 567 (6.2%) BI-RADS 3, 715 (7.8%) BI-RADS 4, and 55 (0.6%) BI-RADS 5 assessments. The frequency of BI-RADS 3, 4, and 5 assessments was higher in studies performed for diagnostic (7.8%, 14.6%, 1.6%, respectively) than screening (5.2%, 4.0%, 0.1%) indications ( P < 0.01). A total of 663 BI-RADS 4 and 5 lesions were biopsied with 209 (31.5%) malignant and 454 (68.5%) benign outcomes. The overall cancer rate for BI-RADS 3 findings was 1.9% (11 of 567) with no difference observed by study indication (diagnostic, 1.6%; screening, 2.3%; P = 0.76). The positive predictive value (PPV2) of BI-RADS 4 and 5 was higher for diagnostic (29.1%, 154 of 530) than for screening (22.9%, 55 of 240) indications.

Conclusions

Abnormal interpretation rates and PPV2 for MRIs performed for diagnostic indications are higher than for screening indications. Similar to mammography, breast MRI audits should be separated by study indication.

Introduction

Contrast-enhanced breast magnetic resonance imaging (MRI) is the most sensitive modality for detecting breast cancer . The modality is currently used both as an adjunct screening tool to mammography for the evaluation of asymptomatic women at high risk of breast cancer, as well as a diagnostic tool in other settings, such as assessment of the extent of the disease for known cancer diagnosis, surveillance after cancer treatment, or problem solving of inconclusive mammographic or ultrasound findings. To facilitate the increasing use of breast MRI in both the academic and community settings, the American College of Radiology (ACR) has provided recommendations for performing breast MRI in the screening and diagnostic populations and, in 2010, began an accreditation program for breast MRI facilities .

To obtain accreditation, breast MRI centers must use the ACR Breast Imaging Reporting and Data System (BI-RADS) lexicon in reporting breast MRI findings . They must be able to provide biopsy capabilities, either at their own center or a referring facility, for suspicious breast MRI findings recommended for biopsy. In addition, breast MRI centers are required to maintain a medical audit outcome program, which includes follow-up of positive BI-RADS assessments (BI-RADS 3, 4, and 5) and to provide a radiology-pathology correlation for biopsied findings on MRI .

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Materials and Methods

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Study Population

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Breast MR Image Acquisition and Interpretation

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Data Collection

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Biopsy and Pathologic Assessments

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Statistical Analysis

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Results

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Figure 1, Distribution of BI-RADS assessments for all indications. BI-RADS, Breast Imaging Reporting and Data System.

Figure 2, Distribution of BI-RADS assessments by screening and diagnostic indications. BI-RADS, Breast Imaging Reporting and Data System.

Table 1

Interpretation of Lesions Identified on Screening and Diagnostic MRI

Total Screening Diagnostic_P_ Value † Total MRIs performed 5778 3297 2481 Total lesion assessments 9216 5927 3289 Number of lesions with abnormal interpretations (BI-RADS 3, 4, and 5) 1337(14.5) 550(9.3) 787(23.9) <0.01 BI-RADS 3 567(6.2) 310(5.2) 257(7.8) <0.01 BI-RADS 4 715(7.8) 236(4.0) 479(14.6) <0.01 4A \* 214(2.3) 73(1.2) 141(4.3) <0.01 4B \* 310(3.4) 112(1.9) 198(6.0) <0.01 4C \* 77(0.8) 25(0.4) 52(1.6) <0.01 BI-RADS 5 55(0.6) 4(0.1) 51(1.6) <0.01 Abnormal interpretation rate 14.5%(1337/9216) 9.3%(550/5927) 23.9%(787/3289) <0.01

BI-RADS, Breast Imaging Reporting and Data System; MRI, magnetic resonance imaging.

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Table 2

Biopsy Outcomes of Lesions Identified on Screening and Diagnostic MRI

Total Screening Diagnostic_P_ Value † Total MRIs performed 5778 3297 2481 Total lesion assessments 9216 5927 3289 Biopsies performed 734(8.0) 243(4.1) 491(14.9) <0.01 BI-RADS 3 71(0.8) 39(0.7) 32(1.0) 0.11 BI-RADS 4 612(6.6) 200(3.4) 412(12.5) <0.01 4A \* 173(1.9) 56(0.9) 117(3.6) <0.01 4B \* 279(3.0) 101(1.7) 178(5.4) <0.01 4C \* 73(0.8) 23(0.4) 50(1.5) <0.01 BI-RADS 5 51(0.6) 4(0.1) 47(1.4) <0.01 Cancer diagnosis (assessment) 209(2.3) 55(0.9) 154(4.7) <0.01 BI-RADS 3 11(0.1) 7(0.1) 4(0.1) 1.00 BI-RADS 4 162(1.8) 52(0.9) 110(3.3) <0.01 4A \* 17(0.2) 7(0.1) 10(0.3) 0.07 4B \* 73(0.8) 27(0.5) 46(1.4) <0.01 4C \* 46(0.5) 12(0.2) 34(1.0) <0.01 BI-RADS 5 47(0.5) 3(0.1) 44(1.3) <0.01 Cancer detection rate per 1000 examinations \* 36.2 16.7 62.1 PPV2 ‡ 27.1%(209/770) 22.9%(55/240) 29.1%(154/530) PPV3 ‡ 31.5%(209/663) 27.0%(55/204) 33.6%(154/459)

BI-RADS, Breast Imaging Reporting and Data System; MRI, magnetic resonance imaging; PPV, positive predictive value.

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Table 3

Histopathologic Diagnosis of Biopsied Suspicious MRI Lesions ( n = 663)

Histopathology Screening Diagnostic Total Malignant lesions ( n = 209)n = 55(26%)n = 154(74%)n = 209 Invasive ductal carcinoma 31(56%) 68(44%) 99(47%) Invasive lobular carcinoma 3(5.5%) 21(14%) 24(11%) Ductal carcinoma in situ 16(29%) 29(19%) 45(22%) Invasive ductal and lobular carcinoma 2(4%) 13(8%) 15(7%) Other malignant lesions \* 3(5.5%) 23(15%) 26(13%) Benign lesions( n = 454)n = 146(32%)n = 308(68%)n = 454 Fibroadenoma and fibroadenomatoid changes 29(20%) 78(25%) 107(23%) Fibrocystic changes, sclerosing adenosis, columnar change, cysts, epithelial hyperplasia, microcysts, nodular adenosis, ductal ectasia 30(21%) 57(19%) 87(19%) Normal breast tissue 38(26%) 37(12%) 75(17%) Atypia including lobular neoplasia 7(5%) 63(20%) 70(15%) Radiation, inflammation, fat necrosis, fibrosis 11(7.5%) 30(9%) 41(9%) Intraductal papilloma 10(7%) 17(6%) 27(6%) Pseudoangiomatous stromal hyperplasia 8(5%) 14(5%) 22(5%) Other benign findings † 11(7.5%) 6(2%) 17(4%) Radial scar or complex sclerosing lesion 2(1%) 6(2%) 8(2%)

MRI, magnetic resonance imaging; NOS, not otherwise specified.

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Discussion

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