Diagnostic accuracy of breast MRI for patients with suspicious nipple discharge and negative mammography and ultrasound: a prospective study.

OBJECTIVES: To evaluate the diagnostic accuracy of breast MRI in identifying lesions requiring excision for patients with suspicious nipple discharge but normal mammograms and ultrasounds. METHODS: Between September 2013 and May 2019, 106 female participants (mean age 57.9 years) were consecutively included in this prospective multicenter study; 102 were retained for analysis. MRI was considered negative in the absence of suspicious enhancement and positive in cases of ipsilateral abnormal enhancement (BI-RADS 3 to 5). Final diagnoses were based on histological findings of surgical or percutaneous biopsies or at 1-year follow-up. We considered all lesions requiring excision found on pathology (papilloma, atypia, nipple adenomatosis, or cancer) as positive results. We considered spontaneous resolution of the discharge at 1 year as a negative result. RESULTS: MRI showed ipsilateral abnormal enhancement in 54 patients (53%) revealing 46 lesions requiring excision (31 benign papillomas, 5 papillomas with atypia, 2 nipple adenomatosis, and 8 cancers) and 8 benign lesions not requiring excision. No suspicious enhancement was found in the remaining 48 participants (47%). Forty-two were followed up at 1 year with spontaneous resolution of the discharge and six underwent surgery (revealing 2 benign papillomas). MRI diagnostic accuracy for the detection of a lesion requiring excision was as follows: sensitivity 96%, specificity 85%, positive predictive value 85%, and negative predictive value 96%. CONCLUSION: In patients with suspicious nipple discharge and normal mammogram and ultrasound, MRI demonstrates excellent performance to identify lesions for which excision is required. Normal MRI indicates it is safe to propose follow-up only management, thus avoiding unnecessary duct excision. TRIAL REGISTRATION: ClinicalTrials.gov NCT02819362 KEY POINTS: • Breast MRI can be useful for the management of patients with suspicious nipple discharge and negative mammogram and ultrasound. • MRI detected a lesion requiring excision in 46 participants (45%) with unexplained discharge. • If breast MRI is negative, follow-up is a safe alternative for these patients.

A new automated method to evaluate 2D mammographic breast density according to BI-RADS® Atlas Fifth Edition recommendations.

OBJECTIVES: Radiologists' visual assessment of breast mammographic density (BMD) is subject to inter-observer variability. We aimed to develop and validate a new automated software tool mimicking expert radiologists' consensus assessments of 2D BMD, as per BI-RADS V recommendations. METHODS: The software algorithm was developed using a concept of Manhattan distance to compare a patient's mammographic image to reference mammograms with an assigned BMD category. Reference databases were built from a total of 2289 pairs (cranio-caudal and medio-lateral oblique views) of 2D full-field digital mammography (FFDM). Each image was independently assessed for BMD by a consensus of radiologists specialized in breast imaging. A validation set of additional 800 image pairs was evaluated for BMD both by the software and seven blinded radiologists specialized in breast imaging. The median score was used for consensus. Software reproducibility was assessed using FFDM image pairs from 214 patients in the validation set to compare BMD assessment between left and right breasts. RESULTS: The software showed a substantial agreement with the radiologists' consensus (unweighted κ = 0.68, 95% CI 0.64-0.72) when considering the four breast density categories, and an almost perfect agreement (unweighted κ = 0.84, 95% CI 0.80-0.88) when considering clinically significant non-dense (A-B) and dense (C-D) categories. Correlation between left and right breasts was high (rs = 0.87; 95% CI 0.84-0.90). CONCLUSIONS: BMD assessment by the software was strongly correlated to radiologists' consensus assessments of BMD. Its performance should be compared to other methods, and its clinical utility evaluated in a risk assessment model. KEY POINTS: • A new software tool assesses breast density in a standardized way. • The tool mimics radiologists' clinical assessment of breast density. • It may be incorporated in a breast cancer risk assessment model.

Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial.

Importance: Many women dread undergoing mammography, and some may not attend or reattend breast cancer screening because of the discomfort or pain induced by breast compression. Objective: To evaluate the noninferiority of the self-compression mammography technique for reducing breast thickness compared with standard compression. Design, Setting, and Participants: This prospective, parallel-group, noninferiority randomized clinical trial was conducted from May 7, 2013, to October 26, 2015, at 6 cancer care centers in France. Participants were women aged 50 to 75 years, without a history of recent breast surgical procedure or treatment, and who could perform self-compression. Analyses were performed on intention-to-treat basis from January 27, 2017, to March 30, 2018. Interventions: Patients were randomized 1:1 to the self-compression group or the standard compression group. Main Outcomes and Measures: Primary end point was breast thickness expressed as the mean of 4 views: right and left craniocaudal and right and left mediolateral oblique. The predefined noninferiority margin was a difference of 3 mm, with a 1-sided 95% CI. Secondary end points included compression force, image quality, requirement for additional views, pain, and patient satisfaction and radiographer assessment questionnaires. Results: Among the 549 women randomized, 548 (97.3%) completed the trial. Of these, 275 (48.8%) (mean [SD] age, 61.35 [6.34] years) were randomized to the self-compression arm and 273 (48.5%) (mean [SD] age, 60.84 [6.41] years) to the standard compression arm. The difference in the mean thickness between the 2 arms was lower than the noninferiority margin, with an upper 1-sided 95% CI less than 3 mm (-0.17; 95% CI,-∞ to 1.89 mm; P < .05). Compression force was higher in the self-compression group compared with the standard compression arm for the 4 mammographic views. Pain was statistically significantly lower in the self-compression group (n = 274) compared with the standard compression group (n = 269) (median [interquartile range (IQR)] score, 2 [1-5] vs 3 [1-5]; P = .009). No difference was reported in the image quality scores of the 2 groups or in the number of additional views performed (median [IQR] extra views, 2 [2-2] vs 2 [2-3] extra views; P = .64), whatever the indication, including insufficient image quality (29 [16.8%] vs 27 [15.0%] insufficient quality views; P = .65). No adverse effects or pain were reported by the participants after the self-compression mammography. Conclusions and Relevance: Self-compression does not appear to be inferior to standard compression mammography in achieving minimal breast thickness without increasing pain or compromising image quality; this technique may be an effective option for women who want to be involved in their breast examination. Trial Registration: ClinicalTrials.gov identifier: NCT02866591.

Immediate Hypersensitivity to Contrast Agents: The French 5-year CIRTACI Study.

BACKGROUND: Iodinated and gadolinium-based contrast media (ICM; GBCM) induce immediate hypersensitivity (IH) reactions. Differentiating allergic from non-allergic IH is crucial; allergy contraindicates the culprit agent for life. We studied frequency of allergic IH among ICM or GBCM reactors. METHODS: Patients were recruited in 31 hospitals between 2005 and 2009. Clinical symptoms, plasma histamine and tryptase concentrations and skin tests were recorded. Allergic IH was diagnosed by intradermal tests (IDT) with the culprit CM diluted 1:10, "potentially allergic" IH by positive IDT with pure CM, and non-allergic IH by negative IDT. FINDINGS: Among 245 skin-tested patients (ICM = 209; GBCM = 36), allergic IH to ICM was identified in 41 (19.6%) and to GBCM in 10 (27.8%). Skin cross-reactivity was observed in 11 patients with ICM (26.8%) and 5 with GBCM (50%). Allergy frequency increased with clinical severity and histamine and tryptase concentrations (p < 0.0001). Cardiovascular signs were strongly associated with allergy. Non-allergic IH was observed in 152 patients (62%) (ICM:134; GBCM:18). Severity grade was lower (p < 0.0001) and reaction delay longer (11.6 vs 5.6 min; p < 0.001). Potentially allergic IH was diagnosed in 42 patients (17.1%) (ICM:34; GBCM:8). The delay, severity grade, and mediator release were intermediate between the two other groups. INTERPRETATION: Allergic IH accounted for < 10% of cutaneous reactions, and > 50% of life-threatening ones. GBCM and ICM triggered comparable IH reactions in frequency and severity. Cross-reactivity was frequent, especially for GBCM. We propose considering skin testing with pure contrast agent, as it is more sensitive than the usual 1:10 dilution criteria.

Improving digital breast tomosynthesis reading time: A pilot multi-reader, multi-case study using concurrent Computer-Aided Detection (CAD).

PURPOSE: Evaluate concurrent Computer-Aided Detection (CAD) with Digital Breast Tomosynthesis (DBT) to determine impact on radiologist performance and reading time. MATERIALS AND METHODS: The CAD system detects and extracts suspicious masses, architectural distortions and asymmetries from DBT planes that are blended into corresponding synthetic images to form CAD-enhanced synthetic images. Review of CAD-enhanced images and navigation to corresponding planes to confirm or dismiss potential lesions allows radiologists to more quickly review DBT planes. A retrospective, crossover study with and without CAD was conducted with six radiologists who read an enriched sample of 80 DBT cases including 23 malignant lesions in 21 women. Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) compared the readings with and without CAD to determine the effect of CAD on overall interpretation performance. Sensitivity, specificity, recall rate and reading time were also assessed. Multi-reader, multi-case (MRMC) methods accounting for correlation and requiring correct lesion localization were used to analyze all endpoints. AUCs were based on a 0-100% probability of malignancy (POM) score. Sensitivity and specificity were based on BI-RADS scores, where 3 or higher was positive. RESULTS: Average AUC across readers without CAD was 0.854 (range: 0.785-0.891, 95% confidence interval (CI): 0.769,0.939) and 0.850 (range: 0.746-0.905, 95% CI: 0.751,0.949) with CAD (95% CI for difference: -0.046,0.039), demonstrating non-inferiority of AUC. Average reduction in reading time with CAD was 23.5% (95% CI: 7.0-37.0% improvement), from an average 48.2 (95% CI: 39.1,59.6) seconds without CAD to 39.1 (95% CI: 26.2,54.5) seconds with CAD. Per-patient sensitivity was the same with and without CAD (0.865; 95% CI for difference: -0.070,0.070), and there was a small 0.022 improvement (95% CI for difference: -0.046,0.089) in per-lesion sensitivity from 0.790 without CAD to 0.812 with CAD. A slight reduction in specificity with a -0.014 difference (95% CI for difference: -0.079,0.050) and a small 0.025 increase (95% CI for difference: -0.036,0.087) in recall rate in non-cancer cases were observed with CAD. CONCLUSIONS: Concurrent CAD resulted in faster reading time with non-inferiority of radiologist interpretation performance. Radiologist sensitivity, specificity and recall rate were similar with and without CAD.

The challenge of rapid diagnosis in oncology: Diagnostic accuracy and cost analysis of a large-scale one-stop breast clinic.

PURPOSE: Rapid diagnosis is a key issue in modern oncology, for which one-stop breast clinics are a model. We aimed to assess the diagnosis accuracy and procedure costs of a large-scale one-stop breast clinic. PATIENTS AND METHODS: A total of 10,602 individuals with suspect breast lesions attended the Gustave Roussy's regional one-stop breast clinic between 2004 and 2012. The multidisciplinary clinic uses multimodal imaging together with ultrasonography-guided fine needle aspiration for masses and ultrasonography-guided and stereotactic biopsies as needed. Diagnostic accuracy was assessed by comparing one-stop diagnosis to the consolidated diagnosis obtained after surgery or biopsy or long-term monitoring. The medical cost per patient of the care pathway was assessed from patient-level data collected prospectively. RESULTS: Sixty-nine percent of the patients had masses, while 31% had micro-calcifications or other non-mass lesions. In 75% of the cases (87% of masses), an exact diagnosis could be given on the same day. In the base-case analysis (i.e. considering only benign and malignant lesions at one-stop and at consolidated diagnoses), the sensitivity of the one-stop clinic was 98.4%, specificity 99.8%, positive and negative predictive values 99.7% and 99.0%. In the sensitivity analysis (reclassification of suspect, atypical and undetermined lesions), diagnostic sensitivity varied from 90.3% to 98.5% and specificity varied from 94.3% to 99.8%. The mean medical cost per patient of one-stop diagnostic procedure was €420. CONCLUSIONS: One-stop breast clinic can provide timely and cost-efficient delivery of highly accurate diagnoses and serve as models of care for multiple settings, including rapid screening-linked diagnosis.

Measurement of partial L fluorescence yields of bismuth using synchrotron radiation.

Tunable monochromatic photon radiation was used to measure transmission of a bismuth target in the energy range from 7keV to 20keV. Partial L fluorescence yields of bismuth were obtained by combining measurement of the fluorescence induced by photoionization of the bismuth target and X-rays from the radioactive decay of (210)Pb. Several photon energies have been used to successively ionize the L subshells, which allowed detailed analysis of the rearrangement spectra and determination of the X-ray relative intensities of the L1, L2 and L3 series.

Variability and errors when applying the BIRADS mammography classification.

To standardize mammographic reporting, the American College of Radiology mammography developed the Breast Imaging Reporting and Data System (BIRADS) lexicon. However, wide variability is observed in practice in the application of the BIRADS terminology and this leads to classification errors. This review analyses the reasons for variations in BIRADS mammography, describes the types of errors made by readers with illustrated examples, and details BIRADS category 3 which is the most difficult category to use in practice.

CAD in questions/answers Review of the literature.

Generalization of breast screening programs requires an efficient double reading of the mammograms, which allows reduction of false-negative rate, but might be difficult to organize. CAD (Computed Assisted Diagnosis) is dramatically improving and is able to detect suspicious mammographic lesions, either suspicious microcalcifications, masses or architectural distorsions. CAD mammography might complete or substitute to "human" double reading. The aim of this review is to describe major CAD systems commercially available, working of CAD and to present principal results of CAD mammography. Specially, place of CAD within breast screening program, according to the results of recent prospective studies will be discussed.

Psycholinguistic norms for action photographs in French and their relationships with spoken and written latencies.

A set of 142 photographs of actions (taken from Fiez & Tranel, 1997) was standardized in French on name agreement, image agreement, conceptual familiarity, visual complexity, imageability, age of acquisition, and duration of the depicted actions. Objective word frequency measures were provided for the infinitive modal forms of the verbs and for the cumulative frequency of the verbal forms associated with the photographs. Statistics on the variables collected for action items were provided and compared with the statistics on the same variables collected for object items. The relationships between these variables were analyzed, and certain comparisons between the current database and other similar published databases of pictures of actions are reported. Spoken and written naming latencies were also collected for the photographs of actions, and multiple regression analyses revealed that name agreement, image agreement, and age of acquisition are the major determinants of action naming speed. Finally, certain analyses were performed to compare object and action naming times. The norms and the spoken and written naming latencies corresponding to the pictures are available on the Internet (http://www.psy.univ-bpclermont.fr/~pbonin/pbonin-eng.html) and should be of great use to researchers interested in the processing of actions.

French normative data and naming times for action pictures.

The aim of the present study was to provide French normative data for 112 action line drawings. The set of action pictures consisted of 71 drawings taken from Masterson and Druks (1998) and 41 additional drawings. It was standardized on six psycholinguistic variables--that is, name agreement, image agreement, image variability, visual complexity, conceptual familiarity, and age of acquisition (AoA). Naming latencies to the action pictures were collected, and a regression analysis was performed on the naming latencies, with the standardized variables, as well as with word frequency and length, taken as predictors. A reliable influence of AoA, name agreement, and image agreement on the naming latencies was observed. The findings are consistent with previous published studies in other languages. The full set of these norms may be downloaded from www.psychonomic.org/archive/.