ACR Appropriateness Criteria® Female Breast Cancer Screening: 2023 Update.

Early detection of breast cancer from regular screening substantially reduces breast cancer mortality and morbidity. Multiple different imaging modalities may be used to screen for breast cancer. Screening recommendations differ based on an individual's risk of developing breast cancer. Numerous factors contribute to breast cancer risk, which is frequently divided into three major categories: average, intermediate, and high risk. For patients assigned female at birth with native breast tissue, mammography and digital breast tomosynthesis are the recommended method for breast cancer screening in all risk categories. In addition to the recommendation of mammography and digital breast tomosynthesis in high-risk patients, screening with breast MRI is recommended. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

ACR Appropriateness Criteria® Breast Implant Evaluation: 2023 Update.

This document discusses the appropriate initial imaging in both asymptomatic and symptomatic patients with breast implants. For asymptomatic patients with saline implants, no imaging is recommended. If concern for rupture exists, ultrasound is usually appropriate though saline rupture is often clinically evident. The FDA recently recommended patients have an initial ultrasound or MRI examination 5 to 6 years after initial silicone implant surgery and then every 2 to 3 years thereafter. In a patient with unexplained axillary adenopathy with current or prior silicone breast implants, ultrasound and/or mammography are usually appropriate, depending on age. In a patient with concern for silicone implant rupture, ultrasound or MRI without contrast is usually appropriate. In the setting of a patient with breast implants and possible implant-associated anaplastic large cell lymphoma, ultrasound is usually appropriate as the initial imaging. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

ACR Appropriateness Criteria® Palpable Breast Masses: 2022 Update.

Palpable masses in women are the most common symptom associated with breast cancer. This document reviews and evaluates the current evidence for imaging recommendations of palpable masses in women less than 30 to over 40 years of age. There is also a review of several different scenarios and recommendations after initial imaging. Ultrasound is usually the appropriate initial imaging for women under 30 years of age. If ultrasound findings are suspicious or highly suggestive of malignancy (BIRADS 4 or 5), it is usually appropriate to continue with diagnostic tomosynthesis or mammography with image-guided biopsy. No further imaging is recommended if the ultrasound is benign or negative. The patient under 30 years of age with a probably benign ultrasound may undergo further imaging; however, the clinical scenario plays a role in the decision to biopsy. For women between 30 to 39 years of age, ultrasound, diagnostic mammography, tomosynthesis, and ultrasound are usually appropriate. Diagnostic mammography and tomosynthesis are the appropriate initial imaging for women 40 years of age or older, as ultrasound may be appropriate if the patient had a negative mammogram within 6 months of presentation or immediately after mammography findings are suspicious or highly suggestive of malignancy. If the diagnostic mammogram, tomosynthesis, and ultrasound findings are probably benign, no further imaging is necessary unless the clinical scenario indicates a biopsy. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Deep learning denoising of digital breast tomosynthesis: Observer performance study of the effect on detection of microcalcifications in breast phantom images.

BACKGROUND: The noise in digital breast tomosynthesis (DBT) includes x-ray quantum noise and detector readout noise. The total radiation dose of a DBT scan is kept at about the level of a digital mammogram but the detector noise is increased due to acquisition of multiple projections. The high noise can degrade the detectability of subtle lesions, specifically microcalcifications (MCs). PURPOSE: We previously developed a deep-learning-based denoiser to improve the image quality of DBT. In the current study, we conducted an observer performance study with breast radiologists to investigate the feasibility of using deep-learning-based denoising to improve the detection of MCs in DBT. METHODS: We have a modular breast phantom set containing seven 1-cm-thick heterogeneous 50% adipose/50% fibroglandular slabs custom-made by CIRS, Inc. (Norfolk, VA). We made six 5-cm-thick breast phantoms embedded with 144 simulated MC clusters of four nominal speck sizes (0.125-0.150, 0.150-0.180, 0.180-0.212, 0.212-0.250 mm) at random locations. The phantoms were imaged with a GE Pristina DBT system using the automatic standard (STD) mode. The phantoms were also imaged with the STD+ mode that increased the average glandular dose by 54% to be used as a reference condition for comparison of radiologists' reading. Our previously trained and validated denoiser was deployed to the STD images to obtain a denoised DBT set (dnSTD). Seven breast radiologists participated as readers to detect the MCs in the DBT volumes of the six phantoms under the three conditions (STD, STD+, dnSTD), totaling 18 DBT volumes. Each radiologist read all the 18 DBT volumes sequentially, which were arranged in a different order for each reader in a counter-balanced manner to minimize any potential reading order effects. They marked the location of each detected MC cluster and provided a conspicuity rating and their confidence level for the perceived cluster. The visual grading characteristics (VGC) analysis was used to compare the conspicuity ratings and the confidence levels of the radiologists for the detection of MCs. RESULTS: The average sensitivities over all MC speck sizes were 65.3%, 73.2%, and 72.3%, respectively, for the radiologists reading the STD, dnSTD, and STD+ volumes. The sensitivity for dnSTD was significantly higher than that for STD (p < 0.005, two-tailed Wilcoxon signed rank test) and comparable to that for STD+. The average false positive rates were 3.9 ± 4.6, 2.8 ± 3.7, and 2.7 ± 3.9 marks per DBT volume, respectively, for reading the STD, dnSTD, and STD+ images but the difference between dnSTD and STD or STD+ did not reach statistical significance. The overall conspicuity ratings and confidence levels by VGC analysis for dnSTD were significantly higher than those for both STD and STD+ (p ≤ 0.001). The critical alpha value for significance was adjusted to be 0.025 with Bonferroni correction. CONCLUSIONS: This observer study using breast phantom images showed that deep-learning-based denoising has the potential to improve the detection of MCs in noisy DBT images and increase radiologists' confidence in differentiating noise from MCs without increasing radiation dose. Further studies are needed to evaluate the generalizability of these results to the wide range of DBTs from human subjects and patient populations in clinical settings.

ACR Appropriateness Criteria® Imaging After Breast Surgery.

Given that 20% to 40% of women who have percutaneous breast biopsy subsequently undergo breast surgery, knowledge of imaging women with a history of benign (including high-risk) disease or breast cancer is important. For women who had surgery for nonmalignant pathology, the surveillance recommendations are determined by their overall risk. Higher-than-average risk women with a history of benign surgery may require screening mammography starting at an earlier age before 40 and may benefit from screening MRI. For women with breast cancer who have undergone initial excision and have positive margins, imaging with diagnostic mammography or MRI can sometimes guide additional surgical planning. Women who have completed breast conservation therapy for cancer should get annual mammography and may benefit from the addition of MRI or ultrasound to their surveillance regimen. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances in which peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Association of a longitudinal, preclinical ultrasound curriculum with medical student performance.

INTRODUCTION: Point-of-care ultrasound (US) is used in clinical practice across many specialties. Ultrasound (US) curricula for medical students are increasingly common. Optimal timing, structure, and effect of ultrasound education during medical school remains poorly understood. This study aims to retrospectively determine the association between participation in a preclinical, longitudinal US curriculum and medical student academic performance. METHODS: All first-year medical students at a medical school in the Midwest region of the United States were offered a voluntary longitudinal US curriculum. Participants were selected by random lottery. The curriculum consisted of five three-hour hands on-sessions with matching asynchronous content covering anatomy and pathologic findings. Content was paired with organ system blocks in the standard first year curriculum at our medical school. Exam scores between the participating and non-participating students were compared to evaluate the objective impact of US education on performance in an existing curriculum. We hypothesized that there would be an association between participation in the curriculum and improved medical student performance. Secondary outcomes included shelf exam scores for the surgery, internal medicine, neurology clerkships and USMLE Step 1. A multivariable linear regression model was used to evaluate the association of US curriculum participation with student performance. Scores were adjusted for age, gender, MCAT percentile, and science or engineering degree. RESULTS: 76 of 178 students applied to participate in the curriculum, of which 51 were accepted. US curriculum students were compared to non-participating students (n = 127) from the same class. The US curriculum students performed better in cardiovascular anatomy (mean score 92.1 vs. 88.7, p = 0.048 after adjustment for multiple comparisons). There were no significant differences in cumulative cardiovascular exam scores, or in anatomy and cumulative exam scores for the gastroenterology and neurology blocks. The effect of US curriculum participation on cardiovascular anatomy scores was estimated to be an improvement of 3.48 points (95% CI 0.78-6.18). No significant differences were observed for USMLE Step 1 or clerkship shelf exams. There were no significant differences in either preclinical, clerkship or Step 1 score for the 25 students who applied and were not accepted and the 102 who did not apply. CONCLUSIONS: Participation in a preclinical longitudinal US curriculum was associated with improved exam performance in cardiovascular anatomy but not examination of other cardiovascular system concepts. Neither anatomy or comprehensive exam scores for neurology and gastrointestinal organ system blocks were improved.

Effect of Dose Level on Radiologists' Detection of Microcalcifications in Digital Breast Tomosynthesis: An Observer Study with Breast Phantoms.

OBJECTIVES: To compare radiologists' sensitivity, confidence level, and reading efficiency of detecting microcalcifications in digital breast tomosynthesis (DBT) at two clinically relevant dose levels. MATERIALS AND METHODS: Six 5-cm-thick heterogeneous breast phantoms embedded with a total of 144 simulated microcalcification clusters of four speck sizes were imaged at two dose modes by a clinical DBT system. The DBT volumes at the two dose levels were read independently by six MQSA radiologists and one fellow with 1-33 years (median 12 years) of experience in a fully-crossed counter-balanced manner. The radiologist located each potential cluster and rated its conspicuity and his/her confidence that the marked location contained a cluster. The differences in the results between the two dose modes were analyzed by two-tailed paired t-test. RESULTS: Compared to the lower-dose mode, the average glandular dose in the higher-dose mode for the 5-cm phantoms increased from 1.34 to 2.07 mGy. The detection sensitivity increased for all speck sizes and significantly for the two smaller sizes (p <0.05). An average of 13.8% fewer false positive clusters was marked. The average conspicuity rating and the radiologists' confidence level were higher for all speck sizes and reached significance (p <0.05) for the three larger sizes. The average reading time per detected cluster reduced significantly (p <0.05) by an average of 13.2%. CONCLUSION: For a 5-cm-thick breast, an increase in average glandular dose from 1.34 to 2.07 mGy for DBT imaging increased the conspicuity of microcalcifications, improved the detection sensitivity by radiologists, increased their confidence levels, reduced false positive detections, and increased the reading efficiency.

ACR Appropriateness Criteria® Transgender Breast Cancer Screening.

Breast cancer screening recommendations for transgender and gender nonconforming individuals are based on the sex assigned at birth, risk factors, and use of exogenous hormones. Insufficient evidence exists to determine whether transgender people undergoing hormone therapy have an overall lower, average, or higher risk of developing breast cancer compared to birth-sex controls. Furthermore, there are no longitudinal studies evaluating the efficacy of breast cancer screening in the transgender population. In the absence of definitive data, current evidence is based on data extrapolated from cisgender studies and a limited number of cohort studies and case reports published on the transgender community. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

ACR Appropriateness Criteria® Imaging After Mastectomy and Breast Reconstruction.

Mastectomy may be performed to treat breast cancer or as a prophylactic approach in women with a high risk of developing breast cancer. In addition, mastectomies may be performed with or without reconstruction. Reconstruction approaches differ and may be autologous, involving a transfer of tissue (skin, subcutaneous fat, and muscle) from other parts of the body to the chest wall. Reconstruction may also involve implants. Implant reconstruction may occur as a single procedure or as multistep procedures with initial use of an adjustable tissue expander allowing the mastectomy tissues to be stretched without compromising blood supply. Ultimately, a full-volume implant will be placed. Reconstructions with a combination of autologous and implant reconstruction may also be performed. Other techniques such as autologous fat grafting may be used to refine both implant and flap-based reconstruction. This review of imaging in the setting of mastectomy with or without reconstruction summarizes the literature and makes recommendations based on available evidence. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Characterization of Breast Masses in Digital Breast Tomosynthesis and Digital Mammograms: An Observer Performance Study.

RATIONALE AND OBJECTIVES: This study aimed to compare Breast Imaging Reporting and Data System (BI-RADS) assessment of lesions in two-view digital mammogram (DM) to two-view wide-angle digital breast tomosynthesis (DBT) without DM. MATERIALS AND METHODS: With Institutional Review Board approval and written informed consent, two-view DBTs were acquired from 134 subjects and the corresponding DMs were collected retrospectively. The study included 125 subjects with 61 malignant (size: 3.9-36.9 mm, median: 13.4 mm) and 81 benign lesions (size: 4.8-43.8 mm, median: 12.0 mm), and 9 normal subjects. The cases in the two modalities were read independently by six experienced Mammography Quality Standards Act radiologists in a fully crossed counterbalanced manner. The readers were blinded to the prevalence of malignant, benign, or normal cases and were asked to assess the lesions based on the BI-RADS lexicon. The ratings were analyzed by the receiver operating characteristic methodology. RESULTS: Lesion conspicuity was significantly higher (P << .0001) and fewer lesion margins were considered obscured in DBT. The mean area under the receiver operating characteristic curve for the six readers increased significantly (P = .0001) from 0.783 (range: 0.723-0.886) for DM to 0.911 (range: 0.884-0.936) for DBT. Of the 366 ratings for malignant lesions, 343 on DBT and 278 on DM were rated as BI-RADS 4a and above. Of the 486 ratings for benign lesions, 220 on DBT and 206 on DM were rated as BI-RADS 4a and above. On average, 17.8% (65 of 366) more malignant lesions and 2.9% (14 of 486) more benign lesions would be recommended for biopsy using DBT. The inter-radiologist variability was reduced significantly. CONCLUSION: With DBT alone, the BI-RADS assessment of breast lesions and inter-radiologist reliability were significantly improved compared to DM.

Does Direct Radiologist-Patient Verbal Communication Affect Follow-Up Compliance of Probably Benign Assessments?

PURPOSE: The aim of this study was to determine whether direct verbal communication of results by a radiologist affected follow-up compliance rates for probably benign breast imaging findings. METHODS: This study was institutional review board approved and HIPAA compliant. A retrospective search identified all patients from January 1, 2010 to December 31, 2010 who had breast findings newly assessed as probably benign (BI-RADS category 3). Patients were categorized by whether the radiologist or the technologist verbally communicated the result and follow-up recommendation. Patient adherence to 6-, 12-, and 24-month follow-up imaging recommendations was recorded. RESULTS: Compliance data were available for 770 of 819 patients in the study. Overall compliance was 83.0% (639 of 770) for 6-month examinations, 68.1% (524 of 770) for 6- and 12-month examinations, and 57.4% (442 of 770) for 6-, 12-, and 24-month examinations. For patients who initially underwent diagnostic mammography alone, there was no significant difference in compliance between those who had and those who did not have radiologist-patient communication (6 months, 81.9% vs 80.8% [P = .83]; 6 and 12 months, 70.8% vs 67.3% [P = .58]; 6, 12, and 24 months, 54.2% vs 58.4% [P = .53]). For patients who initially underwent diagnostic mammography alone versus ultrasound with or without diagnostic mammography, there was no significant difference in compliance (6 months, 81.1% vs 84.3% [P = .24]; 6 and 12 months, 68.1% vs 68.0% [P = .96]; 6, 12, and 24 months, 57.4% vs 57.4% [P = .00]). CONCLUSIONS: High initial compliance was achieved by radiologist or technologist verbal communication of findings and recommendations. Direct communication by the radiologist did not increase compliance compared with communication by a technologist.

Breast imaging after dark: patient outcomes following evaluation for breast abscess in the emergency department after hours.

In our study, we sought to report the management, clinical outcomes, and follow-up rates of patients who presented for evaluation of breast abscess in the Emergency Department (ED) after hours. A retrospective search of ultrasound reports at our institution identified all patients from January 1, 2009 to June 30, 2013 who were scanned in the ED after hours to evaluate for breast abscess. Patient demographics, clinical information, imaging findings, follow-up rates, and outcomes were reviewed. One hundred eighty-five patients were included in the study. Forty-four percent (86/185) of the patients were diagnosed with abscess based on ultrasound findings in the ED. Twenty-seven percent (23/86) were recently post-operative, and 12 % (10/86) were postpartum/breastfeeding. Mastitis was the diagnosis in the remaining 54 % (99/185). Only 1/86 cases were associated with breast cancer. Seventy-seven percent (66/86) of patients were treated with an invasive procedure; 39 % (26/66) had surgical evacuation, 30 % (20/66) image-guided drainage, 23 % (15/66) bedside or clinic incision and drainage, and 8 % (5/66) palpation-guided fine needle aspiration (FNA). Seventy-seven percent (143/185) of patients had clinical and/or imaging follow-up. Forty-four percent (63/143) had long-term follow-up (≥ 3 months). Almost 50 % of the patients who presented to the ED for evaluation of abscess were diagnosed with abscess while the remaining patients were diagnosed with mastitis. Appropriate clinical and/or imaging follow-up occurred in 77 %. Long-term follow-up (≥ 3 months) occurred more frequently in patients older than 30 years of age. Appropriate follow-up does not occur in approximately one fourth of cases, suggesting that additional clinician and patient education is warranted.

Imaging of breast cancer-related changes after nonsurgical therapy.

OBJECTIVE: The purpose of this article is to review both expected and unexpected thoracic CT manifestations of nonsurgical breast cancer treatment with multimodality imaging correlation. Specific topics include the spectrum of posttherapy changes attributed to chemotherapy and radiation therapy and the spread of breast cancer. CONCLUSION: Thoracic CT is an important tool commonly used for breast cancer staging and surveillance and for diagnostic indications such as shortness of breath and chest pain. Imaging findings can be related to progression of disease or to associated conditions, such as pulmonary embolism. The hallmarks of breast cancer spread in the thorax include pulmonary nodules, enlarged lymph nodes, pleural effusions, thickening or nodularity, and sclerotic or lytic skeletal lesions. Less common findings including pulmonary lymphangitic tumor spread and pericardial metastasis. The findings also may represent the sequelae of surgery, radiation therapy, or chemotherapy for breast cancer. Knowledge of various treatment methods and their expected and unexpected CT findings is important for recognizing treatment-related abnormalities to avoid confusion with breast cancer spread and thereby minimize the risk that unnecessary further diagnostic imaging will be performed.

Imaging of breast cancer-related changes after surgical therapy.

OBJECTIVE: The purpose of this article is to discuss the surgical treatment of breast cancer and its resultant thoracic CT and multimodality imaging manifestations. CONCLUSION: Many breast cancer patients undergo cross-sectional imaging at some point during or after treatment. Thoracic CT is an important modality performed for staging and surveillance. Thoracic CT examinations often show findings related to patients' surgical or adjuvant treatment. The postsurgical changes visible on thoracic CT may include those related to lumpectomy, mastectomy, breast reconstruction, and axillary surgery. Postsurgical complications may also be seen, including fluid collections, infection, fat necrosis, and lymphedema. Recognition and appropriate interpretation of the posttherapeutic spectrum of findings are important to avoid unnecessary diagnostic imaging and minimize patient anxiety.

Breast mass characterization using 3-dimensional automated ultrasound as an adjunct to digital breast tomosynthesis: a pilot study.

OBJECTIVES: The purpose of this study was to retrospectively evaluate the effect of 3-dimensional automated ultrasound (3D-AUS) as an adjunct to digital breast tomosynthesis (DBT) on radiologists' performance and confidence in discriminating malignant and benign breast masses. METHODS: Two-view DBT (craniocaudal and mediolateral oblique or lateral) and single-view 3D-AUS images were acquired from 51 patients with subsequently biopsy-proven masses (13 malignant and 38 benign). Six experienced radiologists rated, on a 13-point scale, the likelihood of malignancy of an identified mass, first by reading the DBT images alone, followed immediately by reading the DBT images with automatically coregistered 3D-AUS images. The diagnostic performance of each method was measured using receiver operating characteristic (ROC) curve analysis and changes in sensitivity and specificity with the McNemar test. After each reading, radiologists took a survey to rate their confidence level in using DBT alone versus combined DBT/3D-AUS as potential screening modalities. RESULTS: The 6 radiologists had an average area under the ROC curve of 0.92 for both modalities (range, 0.89-0.97 for DBT and 0.90-0.94 for DBT/3D-AUS). With a Breast Imaging Reporting and Data System rating of 4 as the threshold for biopsy recommendation, the average sensitivity of the radiologists increased from 96% to 100% (P > .08) with 3D-AUS, whereas the specificity decreased from 33% to 25% (P > .28). Survey responses indicated increased confidence in potentially using DBT for screening when 3D-AUS was added (P < .05 for each reader). CONCLUSIONS: In this initial reader study, no significant difference in ROC performance was found with the addition of 3D-AUS to DBT. However, a trend to improved discrimination of malignancy was observed when adding 3D-AUS. Radiologists' confidence also improved with DBT/3DAUS compared to DBT alone.

Prevalence of malignancy in thyroid nodules with an initial nondiagnostic result after ultrasound guided fine needle aspiration.

The objective of this study was to determine the rate of malignancy in thyroid nodules with an initial nondiagnostic fine needle aspiration. From October 2001 to April 2007, biopsies were performed on 1344 thyroid nodules in our practice. Biopsies were performed on nodules using 25-27 gauge needles, ultrasound guidance and multiple passes using both suction and capillary action. We retrospectively reviewed the results of these biopsies as well as any further management of nodules that received nondiagnostic results (IRB HUM00006459). Following initial biopsy, 295/1344 (21.9%) of nodules received nondiagnostic pathologic results. Of this population, 39 nodules (13.1%) were lost to follow-up. Of the remaining 256 nodules that received a repeat FNA, surgical excision, or greater than 24 months of clinical and imaging follow-up, only five cancers were detected, representing only 2% of the population that received an initial nondiagnostic biopsy result. All of these cancers were papillary neoplasms. When rigorous, ultrasound-guided, fine needle aspiration of thyroid nodules is performed, a nondiagnostic histopathologic result should not be interpreted as suspicious for thyroid cancer. Given the low rate of malignancy in this population (2%), we suggest that clinical and imaging follow-up of these nodules, opposed to repeat sampling, is warranted.

Digital breast tomosynthesis is comparable to mammographic spot views for mass characterization.

PURPOSE: To determine if digital breast tomosynthesis (DBT) performs comparably to mammographic spot views (MSVs) in characterizing breast masses as benign or malignant. MATERIALS AND METHODS: This IRB-approved, HIPAA-compliant reader study obtained informed consent from all subjects. Four blinded Mammography Quality Standards Act-certified academic radiologists individually evaluated DBT images and MSVs of 67 masses (30 malignant, 37 benign) in 67 women (age range, 34-88 years). Images were viewed in random order at separate counterbalanced sessions and were rated for visibility (10-point scale), likelihood of malignancy (12-point scale), and Breast Imaging Reporting and Data System (BI-RADS) classification. Differences in mass visibility were analyzed by using the Wilcoxon matched-pairs signed-ranks test. Reader performance was measured by calculating the area under the receiver operating characteristic curve (A(z)) and partial area index above a sensitivity threshold of 0.90 (A(z)(0.90)) by using likelihood of malignancy ratings. Masses categorized as BI-RADS 4 or 5 were compared with histopathologic analysis to determine true-positive results for each modality. RESULTS: Mean mass visibility ratings were slightly better with DBT (range, 3.2-4.4) than with MSV (range, 3.8-4.8) for all four readers, with one reader's improvement achieving statistical significance (P = .001). The A(z) ranged 0.89-0.93 for DBT and 0.88-0.93 for MSV (P ≥ .23). The A(z)((0.90)) ranged 0.36-0.52 for DBT and 0.25-0.40 for MSV (P ≥ .20). The readers characterized seven additional malignant masses as BI-RADS 4 or 5 with DBT than with MSV, at a cost of five false-positive biopsy recommendations, with a mean of 1.8 true-positive (range, 0-3) and 1.3 false-positive (range, -1 to 4) assessments per reader. CONCLUSION: In this small study, mass characterization in terms of visibility ratings, reader performance, and BI-RADS assessment with DBT was similar to that with MSVs. Preliminary findings suggest that MSV might not be necessary for mass characterization when performing DBT.

Multi-modality CADx: ROC study of the effect on radiologists' accuracy in characterizing breast masses on mammograms and 3D ultrasound images.

RATIONALE AND OBJECTIVES: To investigate the effect of a computer-aided diagnosis (CADx) system on radiologists' performance in discriminating malignant and benign masses on mammograms and three-dimensional (3D) ultrasound (US) images. MATERIALS AND METHODS: Our dataset contained mammograms and 3D US volumes from 67 women (median age, 51; range: 27-86) with 67 biopsy-proven breast masses (32 benign and 35 malignant). A CADx system was designed to automatically delineate the mass boundaries on mammograms and the US volumes, extract features, and merge the extracted features into a multi-modality malignancy score. Ten experienced readers (subspecialty academic breast imaging radiologists) first viewed the mammograms alone, and provided likelihood of malignancy (LM) ratings and Breast Imaging and Reporting System assessments. Subsequently, the reader viewed the US images with the mammograms, and provided LM and action category ratings. Finally, the CADx score was shown and the reader had the opportunity to revise the ratings. The LM ratings were analyzed using receiver-operating characteristic (ROC) methodology, and the action category ratings were used to determine the sensitivity and specificity of cancer diagnosis. RESULTS: Without CADx, readers' average area under the ROC curve, A(z), was 0.93 (range, 0.86-0.96) for combined assessment of the mass on both the US volume and mammograms. With CADx, their average A(z) increased to 0.95 (range, 0.91-0.98), which was borderline significant (P = .05). The average sensitivity of the readers increased from 98% to 99% with CADx, while the average specificity increased from 27% to 29%. The change in sensitivity with CADx did not achieve statistical significance for the individual radiologists, and the change in specificity was statistically significant for one of the radiologists. CONCLUSIONS: A well-trained CADx system that combines features extracted from mammograms and US images may have the potential to improve radiologists' performance in distinguishing malignant from benign breast masses and making decisions about biopsies.

Complicated breast cysts on sonography: is aspiration necessary to exclude malignancy?

RATIONALE AND OBJECTIVES: To determine the incidence of breast cancer in women presenting for fine needle aspiration of sonographically diagnosed complicated breast cysts. MATERIALS AND METHODS: Institutional review board approval was obtained. A retrospective study was performed of 186 consecutive women who presented for fine needle aspiration of 243 sonographic complicated cysts detected by clinical examination or imaging between January 2002 and August 2003. Sonographic complicated cysts were defined as those meeting most but not all criteria for simple cysts similar to current Breast Imaging Reporting and Data System classification. We excluded solid masses, cysts with solid components, intracystic masses, and simple cysts. Prospective mammography, ultrasound, and procedure reports were reviewed. A case was considered positive if cytology, core needle biopsy, or surgical excision was positive for cancer. Final diagnosis was established by biopsy, cytology, clinical resolution, or stability over time. RESULTS: One of 243 (0.4%) lesions proved malignant (95% confidence interval 0-1.94%); 210/243 (86.4%) of cases yielded fluid on aspiration. Of 141 samples submitted to cytology, 138 (97.9%) were benign and 3 (2.1%) atypical. All cases of atypia were benign at surgical excision. Ninety five of 243 (39.1%) aspiration samples with typical cyst fluid were discarded. A total of 33/243 (13.6%) cases did not yield fluid, 1 of which was positive for cancer. Thirty cases underwent core needle or excisional biopsy for imaging discordance with benign results. CONCLUSIONS: Breast cancer presenting as a complicated cyst by ultrasound was rare (0.4%, 95% confidence interval 0-1.94%). These results provide support for classification of complicated cysts as probably benign.

Mammographic density measured with quantitative computer-aided method: comparison with radiologists' estimates and BI-RADS categories.

PURPOSE: To retrospectively compare computer-aided mammographic density estimation (MDEST) with radiologist estimates of percentage density and Breast Imaging Reporting and Data System (BI-RADS) density classification. MATERIALS AND METHODS: Institutional Review Board approval was obtained for this HIPAA-compliant study; patient informed consent requirements were waived. A fully automated MDEST computer program was used to measure breast density on digitized mammograms in 65 women (mean age, 53 years; range, 24-89 years). Pixel gray levels in detected breast borders were analyzed, and dense areas were segmented. Percentage density was calculated by dividing the number of dense pixels by the total number of pixels within the borders. Seven breast radiologists (five trained with MDEST, two not trained) prospectively assigned qualitative BI-RADS density categories and visually estimated percentage density on 260 mammograms. Qualitative BI-RADS assessments were compared with new quantitative BI-RADS standards. The reference standard density for this study was established by allowing the five trained radiologists to manipulate the MDEST gray-level thresholds, which segmented mammograms into dense and nondense areas. Statistical tests performed include Pearson correlation coefficients, Bland-Altman agreement method, kappa statistics, and unpaired t tests. RESULTS: There was a close correlation between the reference standard and radiologist-estimated density (R = 0.90-0.95) and MDEST density (R = 0.89). Untrained radiologists overestimated percentage density by an average of 37%, versus 6% for trained radiologists (P < .001). MDEST showed better agreement with the reference standard (average overestimate, 1%; range, -15% to +18%). MDEST correlated better with percentage density than with qualitative BI-RADS categories. There were large overlaps and ranges of percentage density in qualitative BI-RADS categories 2-4. Qualitative BI-RADS categories correlated poorly with new quantitative BI-RADS categories, and 16 (6%) of 260 views were erroneously classified by MDEST. CONCLUSION: MDEST compared favorably with radiologist estimates of percentage density and is more reproducible than radiologist estimates when qualitative BI-RADS density categories are used. Qualitative and quantitative BI-RADS density assessments differed markedly.