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Etta D Pisano

Publications and source records attributed to Etta D Pisano.

At least 19 recordsLinked to original sources

Correlation of HER-2/neu overexpression with mammography and age distribution in primary breast carcinomas.

RATIONALE AND OBJECTIVES: HER-2/neu is a valuable prognostic and therapeutic marker in primary breast carcinoma. The objective of this study was to determine the mammographic and patient characteristics (age) that correlate with HER-2/neu overexpression in primary breast carcinoma. MATERIALS AND METHODS: HER-2/neu characteristics and preoperative mammograms were available in 498 patients with 543 primary breast carcinomas (526 invasive carcinomas and 17 ductal carcinoma in situ). HER-2/neu status was determined by immunohistochemistry and fluorescence in situ hybridization. For evaluation of patient age distribution, age was divided into 5 groups. For mammography, breast composition and abnormal findings were categorized. Abnormal findings were divided into mass, calcification, architectural distortion, asymmetric density, or none. RESULTS: For age distribution, women under than 50 years had more frequent HER-2/neu overexpression than women aged 60-69 years (P < .05). On mammography, there was no significant correlation between breast composition and HER-2/neu status (P > .05). Calcifications were more significantly frequent in carcinomas with HER-2/neu overexpression (56%) than in those without HER-2/neu overexpression (40%) (P = .001). Of the 242 carcinomas with calcifications on mammography, fine linear morphology was more significantly frequent in carcinomas with HER-2/neu overexpression (20%) when compared with those without HER-2/neu overexpression (10%) (P = .023). Diffuse distribution of calcifications was more common in carcinomas with HER-2/neu overexpression (11%) compared with carcinomas without HER-2/neu overexpression (5%) (P = .051). CONCLUSION: HER-2/neu overexpression in primary breast carcinoma is correlated with patients' age (under age 50) and calcifications at mammography.

Adult↗

The positive predictive value for diagnosis of breast cancer full-field digital mammography versus film-screen mammography in the diagnostic mammographic population.

RATIONALE AND OBJECTIVES: Diagnostic mammography is performed on women with clinical symptoms that suggest breast cancer or women for whom further mammographic evaluation has been requested because of an abnormal screening mammography. We assessed whether the use of full-field digital mammography would improve the positive predictive value (PPV) for the diagnosis of breast cancer in a diagnostic population compared with film-screen mammography. MATERIALS AND METHODS: From January 2002 to December 2003, 11,621 patients underwent diagnostic mammography at the University of North Carolina Hospital, Chapel Hill. Among these 11,621 patients, 1400 lesions in 1121 patients underwent biopsy. We included the biopsy-performed lesions, so PPV3 was used for comparison of PPVs between film-screen mammography and full-field digital mammography. Six breast radiologists interpreted the images using the Breast Imaging Reporting and Data System of the American College of Radiology. PPV3s were compared between film-screen and full-field digital mammography in the entire study cohort and in specified subgroups according to different radiologists, breast density, and lesion type on mammography. The chi(2) and Fisher's exact tests were used for comparison of PPV3s between two modalities of mammography with the Bonferroni procedure for subgroup analysis. RESULTS: In the entire study cohort, PPV3s of full-field digital mammography and film-screen mammography were similar (difference in PPV3,-0.007; 95% confidence interval, -0.081 to 0.068; P = .8602). In predefined subgroups, there was no difference in PPV3 by the radiologist, breast density, or lesion type between two modalities of mammography (P > .005). CONCLUSION: There is no improvement in PPV for the diagnosis of breast cancer with full-field digital mammography compared with film-screen mammography in a large diagnostic population.

Adult↗

Quality control for digital mammography in the ACRIN DMIST trial: part I.

The Digital Mammography Imaging Screening Trial, conducted by the American College of Radiology Imaging Network, is a clinical trial designed to compare the accuracy of full-field digital mammography (FFDM) versus screen-film mammography in a screening population. Five FFDM systems from four manufacturers (Fischer, Fuji, General Electric, and Lorad) were employed in the study at 35 clinical sites. A core physics team devised and implemented tests to evaluate these systems. A detailed description of physics and quality control tests is presented, including estimates of: mean glandular dose, modulation transfer function (MTF), 2D noise power spectra, and signal-to-noise ratio (SNR). The mean glandular doses for the standard breast ranged from 0.79 to 2.98 mGy, with 1.62 mGy being the average across all units and machine types. For the five systems evaluated, the MTF dropped to 50% at markedly different percentages (22% to 87%) of the Nyquist limit, indicating that factors other than detector element (del) size have an important effect on spatial resolution. Noise power spectra and SNR were measured; however, we found that it was difficult to standardize and compare these between units. For each machine type, the performance as measured by the tests was very consistent, and no predictive benefit was seen for many of the tests during the 2-year period of the trial. It was found that, after verification of proper operation during acceptance testing, if systems failed they generally did so suddenly rather than through gradual deterioration of performance. Because of the relatively short duration of this study further, investigation of the long-term failure characteristics of these systems is advisable.

Algorithms↗

Quality control for digital mammography: part II. Recommendations from the ACRIN DMIST trial.

The Digital Mammography Imaging Screening Trial (DMIST), conducted under the auspices of the American College of Radiology Imaging Network (ACRIN), is a clinical trial designed to compare the accuracy of digital versus screen-film mammography in a screening population [E. Pisano et al., ACRIN 6652-Digital vs. Screen-Film Mammography, ACRIN (2001)]. Part I of this work described the Quality Control program developed to ensure consistency and optimal operation of the digital equipment. For many of the tests, there were no failures during the 24 months imaging was performed in DMIST. When systems failed, they generally did so suddenly rather than through gradual deterioration of performance. In this part, the utility and effectiveness of those tests are considered. This suggests that after verification of proper operation, routine extensive testing would be of minimal value. A recommended set of tests is presented including additional and improved tests, which we believe meet the intent and spirit of the Mammography Quality Standards Act regulations to ensure that full-field digital mammography systems are functioning correctly, and consistently producing mammograms of excellent image quality.

Breast↗

Diagnostic architectural and dynamic features at breast MR imaging: multicenter study.

PURPOSE: To prospectively determine the prevalence and predictive value of three-dimensional (3D) and dynamic breast magnetic resonance (MR) imaging and contrast material kinetic features alone and as part of predictive diagnostic models. MATERIALS AND METHODS: The study protocol was approved by the institutional review board or ethics committees of all participating institutions, and informed consent was obtained from all participants. Although study data collection was performed before HIPAA went into effect, standards that would be compliant with HIPAA were adhered to. Data from the International Breast MR Consortium trial 6883 were used in the analysis. Women underwent 3D (minimum spatial resolution, 0.7 x 1.4 x 3 mm; minimal temporal resolution, 4 minutes) and dynamic two-dimensional (temporal resolution, 15 seconds) MR imaging examinations. Readers rated enhancement shape, enhancement distribution, border architecture, enhancement intensity, presence of rim enhancement or internal septations, and the shape of the contrast material kinetic curve. Regression was performed for each feature individually and after adjustment for associated mammographic findings. Multivariate models were also constructed from multiple architectural and dynamic features. Areas under the receiver operating characteristic curve (Az values) were estimated for all models. RESULTS: There were 995 lesions in 854 women (mean age, 53 years +/- 12 [standard deviation]; range, 18-80 years) for whom pathology data were available. The absence of enhancement was associated with an 88% negative predictive value for cancer. Qualitative characterization of the dynamic enhancement pattern was associated with an Az value of 0.66 across all lesion architectures. Focal mass margins (Az = 0.76) and signal intensity (Az = 0.70) were highly predictive imaging features. Multivariate models were constructed with an Az value of 0.880. CONCLUSION: Architectural and dynamic features are important in breast MR imaging interpretation. Multivariate models involving feature assessment have a diagnostic accuracy superior to that of qualitative characterization of the dynamic enhancement pattern.

Adolescent↗

Comparison of calcification specificity in digital mammography using soft-copy display versus screen-film mammography.

OBJECTIVE: The purpose of this study was to compare specificity in the interpretation of calcifications in soft-copy reviewing of digital mammograms versus hard-copy reviewing of screen-film mammograms. MATERIALS AND METHODS: A total of 130 consecutive cases with calcifications (44 malignant and 86 benign) that had been evaluated with needle or surgical biopsy were collected. Both screen-film mammography and soft-copy digital mammography were obtained in the same patients under existing research protocols using Fischer Imaging's SenoScan (n = 71), Lorad's digital mammography system (n = 35), and GE Healthcare's Senographe 2000D (n = 24). Eight trained radiologists scored all lesions--cropped or masked to display just the region of interest--both on screen-film and soft-copy digital mammography with a month between reviews to reduce the effects of learning and memory. A 5-point malignancy scale was used, with 1 as definitely not, 2 as probably not, 3 as possibly, 4 as probably, and 5 as definitely. Reviewers were randomly assigned condition order, and images within each condition were randomly ordered. Repeated measures analysis of variance was used to test for differences between conditions in specificity computed via nonparametric receiver operating characteristic (ROC) study separately for each reviewer and condition. RESULTS: Across all reviewers, the mean specificity for 1 or 2 versus 3, 4, or 5 was 0.803 for screen-film mammography (range, 0.413-0.938; SD +/- 0.166) and 0.833 for soft-copy image (range, 0.375-0.951; SD +/- 0.187). Although not statistically significant (Student's t test p values from 0.19 to 0.99 across all cut points), numeric values of specificity were consistently higher for soft-copy versus screen-film mammography. No statistical significance in specificity was seen using all possible cut points in the 5-point scale, although the primary analysis used the cutpoint for differentiation between benign and malignant cases as 1 or 2 versus 3, 4, or 5. CONCLUSION: No statistically significant difference was shown in specificity achievable using soft-copy digital versus screen-film mammography in this study.

Biopsy↗

A comparative study of mobile electronic data entry systems for clinical trials data collection.

PURPOSE: To determine the speed, accuracy, ease of use, and user satisfaction of various electronic data entry platforms for use in the collection of mammography clinical trials data. METHOD AND MATERIALS: Four electronic data entry platforms were tested: standalone personal digital assistant (PDA), Tablet PC, digitizer Tablet/PDA Hybrid (DTP Hybrid), and digital pen (d-pen). Standard paper data entry was used as control. Each of five radiologist readers was assigned to enter interpretations for 20 screening mammograms using three out of the five data entry methods. Assistants recorded both start and stop data entry times of the radiologists and the number of help requests made. Data were checked for handwriting recognition accuracy for the d-pen platform using handwriting verification software. A user satisfaction survey was administered at the end of each platform reading session. RESULTS: Tablet PC and d-pen were statistically equivalent to conventional pen and paper in initial data entry speed. Average verification time for d-pen was significantly less than secondary electronic data entry of paper forms (p-value <0.001). The number of errors in handwriting recognition for d-pen was less than secondary electronic data entry of the paper forms data. Users were most satisfied with Tablet PC, d-pen, and conventional pen and paper for data entry. CONCLUSIONS: Tablet PC and d-pen are equally fast and easy-to-use data entry methods that are well tolerated by radiologist users. Handwriting recognition review and correction for the d-pen is significantly faster and more accurate than secondary manual keyboard and mouse data entry.

Clinical Trials as Topic↗

MRI detection of distinct incidental cancer in women with primary breast cancer studied in IBMC 6883.

BACKGROUND: Prior single institution studies suggest MRI may improve the assessment of the extent of cancer within the breast, and thus reduce the risk of leaving macroscopic disease in the breast following breast conservation therapy. We report on the rate of MRI and mammography detection of foci of distinct incidental cancer in a prospective, multi center trial involving 426 women with confirmed breast cancer at 15 institutions in the US, Canada, and Germany. METHODS: Women underwent mammography and MRI prior to biopsy of the suspicious index lesion. Additional incidental lesions (IL) greater than 2 cm from the index lesion that were detected by mammography and MRI were noted and characterized. Biopsy recommendations were associated with ILs given an assessment of suspicious or highly suspicous (BiRads 4 and 5). These assessments were considered a positive test. RESULTS: MRI had a significantly higher yield of confirmed cancer ILs than mammography (0.18 (95%CI: 0.142-0.214) for MRI versus 0.072 (95%CI: 0.050-0.100) for mammography). The cancer ILs detected by MRI alone appeared to be similar to those detected by mammography with respect to size and histology. The percentage of biopsies of ILs that resulted in a cancer diagnosis was similar between the modalities (MRI 0.72(95%CI: 0.6-0.81); Mammography 0.85 (95%CI: 0.62-0.96)). CONCLUSIONS: These results suggest that consideration needs to be given regarding the integration of breast MRI into the pretreatment evaluation of women seeking breast conservation therapy.

Biopsy↗

Estrogen-plus-progestin use and mammographic density in postmenopausal women: Women's Health Initiative randomized trial.

BACKGROUND: Increased mammographic density reduces the sensitivity of screening mammography, is associated with increased breast cancer risk, and may be hormone related. We assessed the effect of estrogen-plus-progestin therapy on mammographic density. METHODS: In a racially and ethnically diverse ancillary study of the Women's Health Initiative, we examined data from 413 postmenopausal women who had been randomly assigned to receive daily combined conjugated equine estrogens (0.625 mg) plus medroxyprogesterone acetate (i.e., progestin; 2.5 mg) (n = 202) or daily placebo (n = 211). We assessed the effect of estrogen plus progestin on measured mammographic percent density and abnormal findings over a 1-year and 2-year period. All tests of statistical significance were two-sided and were based on F tests or t tests from mixed-effects models. RESULTS: Mean mammographic percent density increased by 6.0% at year 1, compared with baseline, in the estrogen-plus-progestin group but decreased by 0.9% in the placebo group (difference = 6.9%, 95% confidence interval [CI] = 5.3% to 8.5%; P < .001). The mean changes in mammographic density persisted but were attenuated slightly after 2 years, with an absolute increase of 4.9% in the estrogen-plus-progestin group and a decrease of 0.8% in the placebo group (difference = 5.7%, 95% CI = 4.3% to 7.3%; P < .001). These effects were consistent across racial/ethnic groups but were higher among women aged 70-79 years in the estrogen-plus-progestin group (mean increase at year 1 = 11.6%) than in the placebo group (mean decrease at year 1 = 0.1%) (difference of the means = 11.7%, 95% CI = 8.2% to 15.4%; P < .001, comparing across age groups). At year 1, women who were adherent to treatment in the estrogen-plus-progestin group had a mean increase in density of 7.7% (95% CI = 5.9% to 9.5%), and women in the placebo group had a mean decrease in density of 1.1% (95% CI = 0.3% to 1.9%). Use of estrogen plus progestin was associated with an increased risk of having an abnormal mammogram at year 1 (relative risk = 3.9, 95% CI = 1.5 to 10.2; P = .003), compared with placebo, that was not explained by an increase in density. CONCLUSIONS: Use of up to 2 years of estrogen plus progestin was associated with increases in mammographic density.

Age Factors↗

Diagnostic performance of digital versus film mammography for breast-cancer screening.

BACKGROUND: Film mammography has limited sensitivity for the detection of breast cancer in women with radiographically dense breasts. We assessed whether the use of digital mammography would avoid some of these limitations. METHODS: A total of 49,528 asymptomatic women presenting for screening mammography at 33 sites in the United States and Canada underwent both digital and film mammography. All relevant information was available for 42,760 of these women (86.3 percent). Mammograms were interpreted independently by two radiologists. Breast-cancer status was ascertained on the basis of a breast biopsy done within 15 months after study entry or a follow-up mammogram obtained at least 10 months after study entry. Receiver-operating-characteristic (ROC) analysis was used to evaluate the results. RESULTS: In the entire population, the diagnostic accuracy of digital and film mammography was similar (difference between methods in the area under the ROC curve, 0.03; 95 percent confidence interval, -0.02 to 0.08; P=0.18). However, the accuracy of digital mammography was significantly higher than that of film mammography among women under the age of 50 years (difference in the area under the curve, 0.15; 95 percent confidence interval, 0.05 to 0.25; P=0.002), women with heterogeneously dense or extremely dense breasts on mammography (difference, 0.11; 95 percent confidence interval, 0.04 to 0.18; P=0.003), and premenopausal or perimenopausal women (difference, 0.15; 95 percent confidence interval, 0.05 to 0.24; P=0.002). CONCLUSIONS: The overall diagnostic accuracy of digital and film mammography as a means of screening for breast cancer is similar, but digital mammography is more accurate in women under the age of 50 years, women with radiographically dense breasts, and premenopausal or perimenopausal women. (ClinicalTrials.gov number, NCT00008346.)

Adult↗

American College of Radiology Imaging Network digital mammographic imaging screening trial: objectives and methodology.

This study was approved by the Institutional Review Board (IRB) of the American College of Radiology Imaging Network (ACRIN) and each participating site and by the IRB and the Cancer Therapy Evaluation Program at the National Cancer Institute. The study was monitored by an independent Data Safety and Monitoring Board, which received interim analyses of data to ensure that the study would be terminated early if indicated by trends in the outcomes. The ACRIN, which is funded by the National Cancer Institute, conducted the Digital Mammographic Imaging Screening Trial (DMIST) primarily to compare the diagnostic accuracy of digital and screen-film mammography in asymptomatic women presenting for screening for breast cancer. Over the 25.5 months of enrollment, a total of 49 528 women were included at the 33 participating sites, which used five different types of digital mammography equipment. All participants underwent both screen-film and digital mammography. The digital and screen-film mammograms of each subject were independently interpreted by two radiologists. If findings of either examination were interpreted as abnormal, subsequent work-up occurred according to the recommendations of the interpreting radiologist. Breast cancer status was determined at biopsy or follow-up mammography 11-15 months after study entry. In addition to the measurement of diagnostic accuracy by using the interpretations of mammograms at the study sites, DMIST included evaluations of the relative cost-effectiveness and quality-of-life effects of digital versus screen-film mammography. Six separate reader studies using the de-identified archived DMIST mammograms will also assess the diagnostic accuracy of each of the individual digital mammography machines versus screen-film mammography machines, the effect of breast density on diagnostic accuracy of digital and screen-film mammography, and the effect of different rates of breast cancer on the diagnostic accuracy in a reader study.

Breast Neoplasms↗

The effects of gray scale image processing on digital mammography interpretation performance.

RATIONALE AND OBJECTIVES: To determine the effects of three image-processing algorithms on diagnostic accuracy of digital mammography in comparison with conventional screen-film mammography. MATERIALS AND METHODS: A total of 201 cases consisting of nonprocessed soft copy versions of the digital mammograms acquired from GE, Fischer, and Trex digital mammography systems (1997-1999) and conventional screen-film mammograms of the same patients were interpreted by nine radiologists. The raw digital data were processed with each of three different image-processing algorithms creating three presentations-manufacturer's default (applied and laser printed to film by each of the manufacturers), MUSICA, and PLAHE-were presented in soft copy display. There were three radiologists per presentation. RESULTS: Area under the receiver operating characteristic curve for GE digital mass cases was worse than screen-film for all digital presentations. The area under the receiver operating characteristic for Trex digital mass cases was better, but only with images processed with the manufacturer's default algorithm. Sensitivity for GE digital mass cases was worse than screen film for all digital presentations. Specificity for Fischer digital calcifications cases was worse than screen film for images processed in default and PLAHE algorithms. Specificity for Trex digital calcifications cases was worse than screen film for images processed with MUSICA. CONCLUSION: Specific image-processing algorithms may be necessary for optimal presentation for interpretation based on machine and lesion type.

Algorithms↗

A comparative study of 2D and 3D ultrasonography for evaluation of solid breast masses.

OBJECTIVE: To compare image quality and diagnostic accuracy of 2D with 3D ultrasonography in solid breast masses. METHODS AND MATERIAL: To rate image quality, two radiologists compared lesion contrast and characterization of 507 solid breast masses in 2D and 3D ultrasonography and then graded the 3D imaging in 3-point scale. To characterize the masses, the same radiologists rated the examination for clarity of margin, posterior acoustic feature, and clustered microcalcifications within a mass. In addition, the masses were assigned BI-RADS categories as proposed by the American College of Radiology, criteria using just ultrasonographic features. In the 202 pathologically confirmed cases, sensitivity, specificity, positive predictive value, negative predictive value, and false negative rate for diagnosis of breast cancer in 2D and 3D ultrasonography were assessed. Image quality and diagnostic accuracy were further evaluated according to the size of the masses. RESULTS: Two observers rated 3D imaging superior to 2D imaging in terms of lesion contrast and characterization of the masses. Especially, superiority of 3D ultrasonography in terms of image quality was increasing in more than 10 mm sized masses. However, diagnostic accuracy including sensitivity, specificity, positive predictive value, negative predictive value, and false negative rate for diagnosis of breast cancer of 3D imaging was not different from 2D imaging. CONCLUSION: In spite of superior image quality on 3D ultrasonography, it does not provide additional benefits to diagnostic accuracy for diagnosis of breast cancer.

Adult↗

Comparison of full-field digital mammography to screen-film mammography with respect to contrast and spatial resolution in tissue equivalent breast phantoms.

To determine if the improved contrast resolution of full-field digital mammography (FFDM) with reduced spatial resolution allows for superior or equal phantom object detection compared with screen-film mammography (SFM). Tissue equivalent breast phantoms simulating an adipose to glandular ratio of 50/50,30/70, and 20/80 were imaged according to each manufacturers' recommendation with four full-field digital mammography units (Fuji, Sectra, Fischer, and General Electric) and a screen-film mammography unit (MammoMatII 2000, Siemens, Munich, Germany). A total of 20 images were obtained in both hard- and soft-copy formats. For the purpose of soft-copy display, the screen-film hard-copy images were digitized with a 50 microm micron scanner. Six radiologists, experts in breast imaging, and three physicists, experts in scoring mammography phantoms, participated in a reader study where each reader scored each phantom for visibility of line-pairs and for 24 objects (fibers, clusters of specks, and masses). The data were recorded, entered into a database, and analyzed by a mixed-effect model. The limiting spatial resolution in line-pairs per millimeter visible with the digital units was less, regardless of display modality used, than that provided by the screen-film unit. The difference was statistically significant for the General Electric (p < 0.01) and Fuji digital mammography units (p = 0.03). With respect to the number of visible objects, a statistically significant higher number could be detected with the screen-film unit as compared to the Fischer (p < 0.01) and Sectra (p < 0.01) digital mammography units, but there was no significant difference between the other digital units and screen film. Overall, there was significantly better performance on the 50/50 phantom than with the 30/70 and 20/80 phantoms (p = 0.01, p < 0.01) for object visibility. For the digital mammography units, soft-copy display performed better than hard-copy display for the Fischer and Sectra images, but worse for Fuji and General Electric. In addition, soft-copy display of digitized screen-film images was significantly better than hard-copy display (p =0.02) of the original screen films for object visibility, but worse for spatial resolution. The higher contrast resolution of the FFDM units tested did not result in improved detection of line-pair resolution or objects in the phantoms tested versus screen-film mammography. The phantom performance of a digital mammography unit seems to be influenced by the type of detection task (line-pair resolution versus object visibility), the display modality (soft-copy versus hard-copy) chosen to score the phantoms, and the parenchymal pattern composition of the phantom.

Breast Neoplasms↗

Digital mammography.

In digital mammography, the processes of image acquisition, display, and storage are separated, which allows optimization of each. Radiation transmitted through the breast is absorbed by an electronic detector, the response of which is faithful over a wide range of intensities. Once this information is recorded, it can be displayed by using computer image-processing techniques to allow arbitrary settings of image brightness and contrast, without the need for further exposure to the patient. In this article, the current state of the art in technology for digital mammography and data from clinical trials that support the use of the technology will be reviewed. In addition, several potentially useful applications that are being developed with digital mammography will be described.

Adult↗

Imaging and cancer: research strategy of the American College of Radiology Imaging Network.

The American College of Radiology Imaging Network (ACRIN) is a cooperative group funded by the National Cancer Institute and dedicated to developing and conducting clinical trials of diagnostic imaging and image-guided treatment technologies. ACRIN's six disease site committees are responsible for developing scientific strategies and resultant trials within the framework of ACRIN's five key hypotheses: (a) Screening and early detection with imaging can reduce cancer-specific mortality. (b) Less invasive image-guided therapeutic methods can reduce the mortality and morbidity associated with treating cancer. (c) Molecular-based physiologic and functional imaging can improve the diagnosis and staging of cancer, thus improving treatment. (d) Functional imaging can portray the effectiveness of treatment earlier and more accurately, thus reducing mortality and improving the likelihood of a cure. (e) Informatics and other "smart systems" can improve the evaluation of patients with cancer, thus leading to better and more effective treatments. This article details ACRIN's research strategy according to disease site through the year 2007.

Breast Neoplasms↗

Magnetic resonance imaging of the breast prior to biopsy.

CONTEXT: Breast magnetic resonance imaging (MRI) has been shown to have high sensitivity for cancer detection and is increasingly used following mammography to evaluate suspicious breast lesions. OBJECTIVE: To determine the accuracy of breast MRI in conjunction with mammography for the detection of breast cancer in patients with suspicious mammographic or clinical findings. DESIGN, SETTING, AND PATIENTS: Prospective multicenter investigation of the International Breast MR Consortium conducted at 14 university hospitals in North America and Europe from June 2, 1998, through October 31, 2001, of 821 patients referred for breast biopsy for American College of Radiology category 4 or 5 mammographic assessment or suspicious clinical or ultrasound finding. INTERVENTIONS: MRI examinations performed prior to breast biopsy; MRI results were interpreted at each site, which were blinded to pathological results. MAIN OUTCOME MEASURES: Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of breast MRI. RESULTS: Among the 821 patients, there were 404 malignant index lesions, of which 63 were ductal carcinoma in situ (DCIS) and 341 were invasive carcinoma. Of the 417 nonmalignant index lesions, 366 were benign, 47 showed atypical histology, and 4 were lobular carcinoma in situ. The AUC pooled over all institutions was 0.88 (95% confidence interval [CI], 0.86-0.91). MRI correctly detected cancer in 356 of 404 cancer cases (DCIS or invasive cancer), resulting in a sensitivity of 88.1% (95% CI, 84.6%-91.1%), and correctly identified as negative for cancer 281 of 417 cases without cancer, resulting in a specificity of 67.7% (95% CI, 62.7%-71.9%). MRI performance was not significantly affected by mammographic breast density, tumor histology, or menopausal status. The positive predictive values for 356 of 492 patients was 72.4% (95% CI, 68.2%-76.3%) and of mammography for 367 of 695 patients was 52.8% (95% CI, 49.0%-56.6%) (P<.005). Dynamic MRI did not improve the AUC compared with 3-dimensional MRI alone, but the specificity of a washout pattern for 123 of 136 patients without cancer was 90.4% (95% CI, 84%-95%). CONCLUSIONS: Breast MRI has high sensitivity but only moderate specificity independent of breast density, tumor type, and menopausal status. Although the positive predictive value of MRI is greater than mammography, MRI does not obviate the need for subsequent tissue sampling in this setting.

Adult↗