Ultrasound versus MRI for evaluation of silicone leakage from silicone breast implants.

Background: Implant ruptures and gel bleed are not uncommon among women with silicone breast implants. While magnetic resonance imaging (MRI) is traditionally considered the gold standard diagnostic modality, recent studies suggest ultrasound might be an acceptable alternative. This study compares the efficacy of ultrasound and MRI in assessing implant integrity. Methods: Women with silicone breast implants underwent a breast and axillary ultrasound and MRI on the same day. All tests were assessed by experienced radiologists. The accuracy, sensitivity, and specificity of ultrasound and MRI for implant rupture detection and silicone depositions in axillary lymph nodes were evaluated. Findings: A total of 104 women participated in the study. The accuracy, sensitivity, and specificity of ultrasound for detecting implant ruptures compared to MRI were 96 %, 95 %, and 96 %, respectively. MRI demonstrated significantly lower sensitivity (44 %) for detecting silicone depositions in axillary lymph nodes compared to ultrasound. A significant association was observed between the presence of enlarged axillary lymph nodes and/or axillary pain and the detection of silicone depositions in axillary lymph nodes on ultrasound (χ2 (1, N = 104) = 5·1, p = 0·024). Six women exhibited silicone depositions in axillary lymph nodes despite having intact first-pair implants, indicative of gel bleed. Interpretation: Ultrasound is nearly as effective as MRI for detecting breast implant ruptures and is superior for detecting silicone depositions in axillary lymph nodes. We therefore recommend initiating radiological examination in women with breast implants with a breast and axillary ultrasound, proceeding to MRI only if the ultrasound is inconclusive. The prevalence of gel bleed is understudied and its potential adverse health effects might be underestimated. Further research is needed to explore its potential association with development of systemic symptoms.

Contrast-enhanced mammography versus conventional imaging in women recalled from breast cancer screening (RACER trial): a multicentre, open-label, randomised controlled clinical trial.

Background: Women recalled from breast cancer screening receive post-screening work-up in the hospital with conventional breast imaging. The RACER trial aimed to study whether contrast-enhanced mammography (CEM) as primary imaging instead of conventional imaging resulted in more accurate and efficient diagnostic work-up in recalled women. Methods: In this randomised, controlled trial (registered under NL6413/NTR6589) participants were allocated using deterministic minimisation to CEM or conventional imaging as a primary work-up tool in two general and two academic hospitals. Predefined patients' factors were reason for recall, BI-RADS score, and study centre. Primary outcomes were sensitivity and specificity. Secondary outcomes were the proportion of women needing supplemental examinations, and number of days until diagnosis. Findings: Between April, 2018, and September, 2021, 529 patients recalled from the Dutch screening program were randomised, 265 to conventional imaging and 264 to CEM. Three patients in the control arm had to be excluded from analysis due to a protocol breach. After the entire work-up, sensitivity was 98.0% (95% CI; 92.2-99.7%) in the intervention arm and 97.7% (91.8-99.6%) in the control arm (p = 1.0), and specificity was 75.6% (72.5-76.6%) and 75.4% (72.5-76.4%, p = 1.0), respectively. Based on only primary full-field digital mammography/digital breast tomosynthesis or CEM, final diagnosis was reached in 27.7% (73/264) in the intervention arm and 1.1% (3/262) in the control arm. The frequency of supplemental imaging was significantly higher in the control arm (p < 0.0001). Median time needed to reach final diagnosis was comparable: 1 day (control arm: IQR 0-4; intervention arm: IQR 0-3). Thirteen malignant occult lesions were detected using CEM, versus three using conventional imaging. No serious adverse events occurred. Interpretation: Diagnostic accuracy of CEM in the work-up of recalled women is comparable with conventional imaging. However, work-up with CEM as primary imaging is a more efficient pathway. Funding: ZonMw (grant number 843001801) and GE Healthcare.

Re-attendance in supplemental breast MRI screening rounds of the DENSE trial for women with extremely dense breasts.

OBJECTIVES: Supplemental MRI screening improves early breast cancer detection and reduces interval cancers in women with extremely dense breasts in a cost-effective way. Recently, the European Society of Breast Imaging recommended offering MRI screening to women with extremely dense breasts, but the debate on whether to implement it in breast cancer screening programs is ongoing. Insight into the participant experience and willingness to re-attend is important for this discussion. METHODS: We calculated the re-attendance rates of the second and third MRI screening rounds of the DENSE trial. Moreover, we calculated age-adjusted odds ratios (ORs) to study the association between characteristics and re-attendance. Women who discontinued MRI screening were asked to provide one or more reasons for this. RESULTS: The re-attendance rates were 81.3% (3458/4252) and 85.2% (2693/3160) in the second and third MRI screening round, respectively. A high age (> 65 years), a very low BMI, lower education, not being employed, smoking, and no alcohol consumption were correlated with lower re-attendance rates. Moderate or high levels of pain, discomfort, or anxiety experienced during the previous MRI screening round were correlated with lower re-attendance rates. Finally, a plurality of women mentioned an examination-related inconvenience as a reason to discontinue screening (39.1% and 34.8% in the second and third screening round, respectively). CONCLUSIONS: The willingness of women with dense breasts to re-attend an ongoing MRI screening study is high. However, emphasis should be placed on improving the MRI experience to increase the re-attendance rate if widespread supplemental MRI screening is implemented. CLINICAL RELEVANCE STATEMENT: For many women, MRI is an acceptable screening method, as re-attendance rates were high - even for screening in a clinical trial setting. To further enhance the (re-)attendance rate, one possible approach could be improving the overall MRI experience. KEY POINTS: • The willingness to re-attend in an ongoing MRI screening study is high. • Pain, discomfort, and anxiety in the previous MRI screening round were related to lower re-attendance rates. • Emphasis should be placed on improving MRI experience to increase the re-attendance rate in supplemental MRI screening.

Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial-a study protocol.

BACKGROUND: Partial breast irradiation (PBI) is standard of care in low-risk breast cancer patients after breast-conserving surgery (BCS). Pre-operative PBI can result in tumor downstaging and more precise target definition possibly resulting in less treatment-related toxicity. This study aims to assess the pathologic complete response (pCR) rate one year after MR-guided single-dose pre-operative PBI in low-risk breast cancer patients. METHODS: The ABLATIVE-2 trial is a multicenter prospective single-arm trial using single-dose ablative PBI in low-risk breast cancer patients. Patients ≥ 50 years with non-lobular invasive breast cancer ≤ 2 cm, grade 1 or 2, estrogen receptor-positive, HER2-negative, and tumor-negative sentinel node procedure are eligible. A total of 100 patients will be enrolled. PBI treatment planning will be performed using a radiotherapy planning CT and -MRI in treatment position. The treatment delivery will take place on a conventional or MR-guided linear accelerator. The prescribed radiotherapy dose is a single dose of 20 Gy to the tumor, and 15 Gy to the 2 cm of breast tissue surrounding the tumor. Follow-up MRIs, scheduled at baseline, 2 weeks, 3, 6, 9, and 12 months after PBI, are combined with liquid biopsies to identify biomarkers for pCR prediction. BCS will be performed 12 months after radiotherapy or after 6 months, if MRI does not show a radiologic complete response. The primary endpoint is the pCR rate after PBI. Secondary endpoints are radiologic response, toxicity, quality of life, cosmetic outcome, patient distress, oncological outcomes, and the evaluation of biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 10 years after radiation therapy. DISCUSSION: This trial will investigate the pathological tumor response after pre-operative single-dose PBI after 12 months in patients with low-risk breast cancer. In comparison with previous trial outcomes, a longer interval between PBI and BCS of 12 months is expected to increase the pCR rate of 42% after 6-8 months. In addition, response monitoring using MRI and biomarkers will help to predict pCR. Accurate pCR prediction will allow omission of surgery in future patients. TRIAL REGISTRATION: The trial was registered prospectively on April 28th 2022 at clinicaltrials.gov (NCT05350722).

Preoperative Partial Breast Irradiation in Patients with Low-Risk Breast Cancer: A Systematic Review of Literature.

BACKGROUND: Preoperative instead of standard postoperative partial breast irradiation (PBI) after breast-conserving surgery (BCS) has the advantage of reducing the irradiated breast volume, toxicity, and number of radiotherapy sessions and can allow tumor downstaging. In this review, we assessed tumor response and clinical outcomes after preoperative PBI. PATIENTS AND METHODS: We conducted a systematic review of studies on preoperative PBI in patients with low-risk breast cancer using the databases Ovid Medline, Embase.com, Web of Science (Core Collection), and Scopus (PROSPERO registration CRD42022301435). References of eligible manuscripts were checked for other relevant manuscripts. The primary outcome measure was pathologic complete response (pCR). RESULTS: A total of eight prospective and one retrospective cohort study were identified (n = 359). In up to 42% of the patients, pCR was obtained and this increased after a longer interval between radiotherapy and BCS (0.5-8 months). After a maximum median follow-up of 5.0 years, three studies on external beam radiotherapy reported low local recurrence rates (0-3%) and overall survival of 97-100%. Acute toxicity consisted mainly of grade 1 skin toxicity (0-34%) and seroma (0-31%). Late toxicity was predominantly fibrosis grade 1 (46-100%) and grade 2 (10-11%). Cosmetic outcome was good to excellent in 78-100% of the patients. CONCLUSIONS: Preoperative PBI showed a higher pCR rate after a longer interval between radiotherapy and BCS. Mild late toxicity and good oncological and cosmetic outcomes were reported. In the ongoing ABLATIVE-2 trial, BCS is performed at a longer interval of 12 months after preoperative PBI aiming to achieve a higher pCR rate.

Predicting breast cancer types on and beyond molecular level in a multi-modal fashion.

Accurately determining the molecular subtypes of breast cancer is important for the prognosis of breast cancer patients and can guide treatment selection. In this study, we develop a deep learning-based model for predicting the molecular subtypes of breast cancer directly from the diagnostic mammography and ultrasound images. Multi-modal deep learning with intra- and inter-modality attention modules (MDL-IIA) is proposed to extract important relations between mammography and ultrasound for this task. MDL-IIA leads to the best diagnostic performance compared to other cohort models in predicting 4-category molecular subtypes with Matthews correlation coefficient (MCC) of 0.837 (95% confidence interval [CI]: 0.803, 0.870). The MDL-IIA model can also discriminate between Luminal and Non-Luminal disease with an area under the receiver operating characteristic curve of 0.929 (95% CI: 0.903, 0.951). These results significantly outperform clinicians' predictions based on radiographic imaging. Beyond molecular-level test, based on gene-level ground truth, our method can bypass the inherent uncertainty from immunohistochemistry test. This work thus provides a noninvasive method to predict the molecular subtypes of breast cancer, potentially guiding treatment selection for breast cancer patients and providing decision support for clinicians.

Reducing False-Positive Screening MRI Rate in Women with Extremely Dense Breasts Using Prediction Models Based on Data from the DENSE Trial.

Background High breast density increases breast cancer risk and lowers mammographic sensitivity. Supplemental MRI screening improves cancer detection but increases the number of false-positive screenings. Thus, methods to distinguish true-positive MRI screening results from false-positive ones are needed. Purpose To build prediction models based on clinical characteristics and MRI findings to reduce the rate of false-positive screening MRI findings in women with extremely dense breasts. Materials and Methods Clinical characteristics and MRI findings in Dutch breast cancer screening participants (age range, 50-75 years) with positive first-round MRI screening results (Breast Imaging Reporting and Data System 3, 4, or 5) after a normal screening mammography with extremely dense breasts (Volpara density category 4) were prospectively collected within the randomized controlled Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial from December 2011 through November 2015. In this secondary analysis, prediction models were built using multivariable logistic regression analysis to distinguish true-positive MRI screening findings from false-positive ones. Results Among 454 women (median age, 52 years; interquartile range, 50-57 years) with a positive MRI result in a first supplemental MRI screening round, 79 were diagnosed with breast cancer (true-positive findings), and 375 had false-positive MRI results. The full prediction model (area under the receiver operating characteristics curve [AUC], 0.88; 95% CI: 0.84, 0.92), based on all collected clinical characteristics and MRI findings, could have prevented 45.5% (95% CI: 39.6, 51.5) of false-positive recalls and 21.3% (95% CI: 15.7, 28.3) of benign biopsies without missing any cancers. The model solely based on readily available MRI findings and age had a comparable performance (AUC, 0.84; 95% CI: 0.79, 0.88; P = .15) and could have prevented 35.5% (95% CI: 30.4, 41.1) of false-positive MRI screening results and 13.0% (95% CI: 8.8, 18.6) of benign biopsies. Conclusion Prediction models based on clinical characteristics and MRI findings may be useful to reduce the false-positive first-round screening MRI rate and benign biopsy rate in women with extremely dense breasts. Clinical trial registration no. NCT01315015 © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Imbriaco in this issue.

Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial.

Background In the first (prevalent) supplemental MRI screening round of the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial, a considerable number of breast cancers were found at the cost of an increased false-positive rate (FPR). In incident screening rounds, a lower cancer detection rate (CDR) is expected due to a smaller pool of prevalent cancers, and a reduced FPR, due to the availability of prior MRI examinations. Purpose To investigate screening performance indicators of the second round (incidence round) of the DENSE trial. Materials and Methods The DENSE trial (ClinicalTrials.gov: NCT01315015) is embedded within the Dutch population-based biennial mammography screening program for women aged 50-75 years. MRI examinations were performed between December 2011 and January 2016. Women were eligible for the second round when they again had a negative screening mammogram 2 years after their first MRI. The recall rate, biopsy rate, CDR, FPR, positive predictive values, and distributions of tumor characteristics were calculated and compared with results of the first round using 95% CIs and χ2 tests. Results A total of 3436 women (median age, 56 years; interquartile range, 48-64 years) underwent a second MRI screening. The CDR was 5.8 per 1000 screening examinations (95% CI: 3.8, 9.0) compared with 16.5 per 1000 screening examinations (95% CI: 13.3, 20.5) in the first round. The FPR was 26.3 per 1000 screening examinations (95% CI: 21.5, 32.3) in the second round versus 79.8 per 1000 screening examinations (95% CI: 72.4, 87.9) in the first round. The positive predictive value for recall was 18% (20 of 110 participants recalled; 95% CI: 12.1, 26.4), and the positive predictive value for biopsy was 24% (20 of 84 participants who underwent biopsy; 95% CI: 16.0, 33.9), both comparable to that of the first round. All tumors in the second round were stage 0-I and node negative. Conclusion The incremental cancer detection rate in the second round was 5.8 per 1000 screening examinations-compared with 16.5 per 1000 screening examinations in the first round. This was accompanied by a strong reduction in the number of false-positive results. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Moy and Gao in this issue.

Optimization of Wire-guided Technique With Bracketing Reduces Resection Volumes in Breast-conserving Surgery for Early Breast Cancer.

BACKGROUND: Wire-guided localization (WGL) of early breast cancer can be facilitated using multiple wires, which is called bracketing wire-guided localization (BWL). The primary aim of this study is to compare BWL and conventional WGL regarding minimization of resection volumes without compromising margin status. Secondly, BWL is evaluated as an alternative method for intraoperative ultrasound (US) guidance in poorly definable breast tumors on US. PATIENTS AND METHODS: In this retrospective cohort study, patients with preoperatively diagnosed breast cancer undergoing wide local excision between January 2016 and December 2018 were analyzed. Patients with multifocal disease or neoadjuvant treatment were excluded from this study. Optimal resection with minimal healthy breast tissue removal was assessed using the calculated resection ratio (CRR). RESULTS: BWL was performed in 17 (9%) patients, WGL in 44 (22%), and US in 139 (70%). The rate of negative margins was comparable in all 3 groups. The CRR was significantly smaller for BWL (0.6) than WGL (1.3) in tumors larger than 1.5 cm. Additionally, BWL (0.8) led to smaller CRRs than US (1.7). This could be explained by the high number of small tumors (≤ 1.5 cm) in the US group for which greater CRRs are obtained than for large tumors (> 1.5 cm) (1.9 vs. 1.4; P = .005). CONCLUSION: For breast tumors larger than 1.5 cm, BWL achieves more optimal resection volumes without compromising margin status compared with WGL. Moreover, BWL seems a suitable alternative to US in patients with poorly ultrasound-visible breast tumors and patients with a small tumor in a (large) breast.

Can We Identify or Exclude Extensive Axillary Nodal Involvement in Breast Cancer Patients Preoperatively?

BACKGROUND: Breast cancer treatment has rapidly changed in the last few years. Particularly, treatment of patients with axillary nodal involvement has evolved after publication of several randomized clinical trials. Omitting axillary lymph node dissection in selected early breast cancer patients with one or two positive sentinel nodes did not compromise overall survival nor regional disease control in these trials. Hence, either excluding or identifying extensive axillary nodal involvement becomes increasingly important. PURPOSE: To evaluate whether the current diagnostic modalities can accurately identify or exclude extensive axillary nodal involvement. Evaluated modalities were axillary ultrasound, ultrasound-guided needle biopsy, MRI, and PET/CT. METHODS: A literature search was performed in the Cochrane Library, EMBASE, and PubMed databases up to June 2019. The search strategy included terms for breast cancer, lymph nodes, and the different imaging modalities. Only articles that reported pathological N-stage or the total number of positive axillary lymph nodes were considered for inclusion. Studies with patients undergoing neoadjuvant systemic therapy were excluded. CONCLUSION: There is no evidence that any of the current preoperative axillary imaging modalities can accurately exclude or identify breast cancer patients with extensive nodal involvement. Both negative PET/CT and negative MRI scans (with gadolinium-based contrast agents) are promising in excluding extensive nodal involvement. Larger studies should be performed to strengthen this conclusion. False-negative rates of axillary ultrasound and ultrasound-guided needle biopsy are too high to rely on negative results of these modalities in excluding extensive nodal involvement.

Supplemental MRI Screening for Women with Extremely Dense Breast Tissue.

BACKGROUND: Extremely dense breast tissue is a risk factor for breast cancer and limits the detection of cancer with mammography. Data are needed on the use of supplemental magnetic resonance imaging (MRI) to improve early detection and reduce interval breast cancers in such patients. METHODS: In this multicenter, randomized, controlled trial in the Netherlands, we assigned 40,373 women between the ages of 50 and 75 years with extremely dense breast tissue and normal results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The groups were assigned in a 1:4 ratio, with 8061 in the MRI-invitation group and 32,312 in the mammography-only group. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period. RESULTS: The interval-cancer rate was 2.5 per 1000 screenings in the MRI-invitation group and 5.0 per 1000 screenings in the mammography-only group, for a difference of 2.5 per 1000 screenings (95% confidence interval [CI], 1.0 to 3.7; P<0.001). Of the women who were invited to undergo MRI, 59% accepted the invitation. Of the 20 interval cancers that were diagnosed in the MRI-invitation group, 4 were diagnosed in the women who actually underwent MRI (0.8 per 1000 screenings) and 16 in those who did not accept the invitation (4.9 per 1000 screenings). The MRI cancer-detection rate among the women who actually underwent MRI screening was 16.5 per 1000 screenings (95% CI, 13.3 to 20.5). The positive predictive value was 17.4% (95% CI, 14.2 to 21.2) for recall for additional testing and 26.3% (95% CI, 21.7 to 31.6) for biopsy. The false positive rate was 79.8 per 1000 screenings. Among the women who underwent MRI, 0.1% had either an adverse event or a serious adverse event during or immediately after the screening. CONCLUSIONS: The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography resulted in the diagnosis of significantly fewer interval cancers than mammography alone during a 2-year screening period. (Funded by the University Medical Center Utrecht and others; DENSE ClinicalTrials.gov number, NCT01315015.).

Summarizing the 4D image stack of ultrafast dynamic contrast enhancement MRI of breast cancer in 3D using color intensity projections.

BACKGROUND: Each ultrafast dynamic contrast-enhanced (DCE) MRI sequence for breast cancer generates thousands of images in a 4D stack that need to be reviewed by a radiologist. PURPOSE: To assess whether color intensity projections (CIP) effectively summarizes-using only the time of arrival (ToA) and amount of signal enhancement (AoE) of the contrast agent-the thousands of ultrafast images. STUDY TYPE: Retrospective cohort clinical trial. SUBJECTS: The study included 89 patients who had been scanned with an MRI beast protocol, of which 26 had breast cancer and 63 did not. FIELD STRENGTH/SEQUENCE: The 115-second ultrafast DCE sequence at 3T acquired 19 consecutive frames every 4.26 seconds with 152 slices per frame, yielding a 4D stack with 2888 2D images for each of water and fat. ASSESSMENT: For each slice of the water 4D stack a single CIP image was generated that encoded the ToA in the hue (red, orange, yellow, green, cyan, blue) and AoE in the brightness. Each of three experienced radiologists assigned a Breast Imaging and Reporting Data System (BI-RADS) score for each patient, first using only the CIP images, and subsequently using both CIP and the full 4D stack. STATISTICAL TESTS: The one-sided Fisher's exact test was used to determine statistical significance of both the sensitivity and specificity between the CIP alone and the CIP plus 4D stack. RESULTS: All malignancies were detected using only CIP by at least one of the radiologists. The CIP and CIP+4D sensitivities for reader 1 were 96% and 96% (P = 0.57), specificities were 59% and 65% (P = 0.29). For reader 2, the values were 96% and 100% (P = 0.51) with 62% and 71% (P = 0.17). For reader 3 the values were 92% and 96% (P = 0.50) with 51% and 62% (P = 0.07). DATA CONCLUSION: With a 95% sensitivity, CIP provides an effective summary of ultrafast DCE images of breast cancer. LEVEL OF EVIDENCE: 3 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;49:1391-1399.

Multireader Study on the Diagnostic Accuracy of Ultrafast Breast Magnetic Resonance Imaging for Breast Cancer Screening.

OBJECTIVES: Breast cancer screening using magnetic resonance imaging (MRI) has limited accessibility due to high costs of breast MRI. Ultrafast dynamic contrast-enhanced breast MRI can be acquired within 2 minutes. We aimed to assess whether screening performance of breast radiologist using an ultrafast breast MRI-only screening protocol is as good as performance using a full multiparametric diagnostic MRI protocol (FDP). MATERIALS AND METHODS: The institutional review board approved this study, and waived the need for informed consent. Between January 2012 and June 2014, 1791 consecutive breast cancer screening examinations from 954 women with a lifetime risk of more than 20% were prospectively collected. All women were scanned using a 3 T protocol interleaving ultrafast breast MRI acquisitions in a full multiparametric diagnostic MRI protocol consisting of standard dynamic contrast-enhanced sequences, diffusion-weighted imaging, and T2-weighted imaging. Subsequently, a case set was created including all biopsied screen-detected lesions in this period (31 malignant and 54 benign) and 116 randomly selected normal cases with more than 2 years of follow-up. Prior examinations were included when available. Seven dedicated breast radiologists read all 201 examinations and 153 available priors once using the FDP and once using ultrafast breast MRI only in 2 counterbalanced and crossed-over reading sessions. RESULTS: For reading the FDP versus ultrafast breast MRI alone, sensitivity was 0.86 (95% confidence interval [CI], 0.81-0.90) versus 0.84 (95% CI, 0.78-0.88) (P = 0.50), specificity was 0.76 (95% CI, 0.74-0.79) versus 0.82 (95% CI, 0.79-0.84) (P = 0.002), positive predictive value was 0.40 (95% CI, 0.36-0.45) versus 0.45 (95% CI, 0.41-0.50) (P = 0.14), and area under the receiver operating characteristics curve was 0.89 (95% CI, 0.82-0.96) versus 0.89 (95% CI, 0.82-0.96) (P = 0.83). Ultrafast breast MRI reading was 22.8% faster than reading FDP (P < 0.001). Interreader agreement is significantly better for ultrafast breast MRI (κ = 0.730; 95% CI, 0.699-0.761) than for the FDP (κ = 0.665; 95% CI, 0.633-0.696). CONCLUSIONS: Breast MRI screening using only an ultrafast breast MRI protocol is noninferior to screening with an FDP and may result in significantly higher screening specificity and shorter reading time.

MR Imaging as an Additional Screening Modality for the Detection of Breast Cancer in Women Aged 50-75 Years with Extremely Dense Breasts: The DENSE Trial Study Design.

Women with extremely dense breasts have an increased risk of breast cancer and lower mammographic tumor detectability. Nevertheless, in most countries, these women are currently screened with mammography only. Magnetic resonance (MR) imaging has the potential to improve breast cancer detection at an early stage because of its higher sensitivity. However, MR imaging is more expensive and is expected to be accompanied by an increase in the number of false-positive results and, possibly, an increase in overdiagnosis. To study the additional value of MR imaging, a randomized controlled trial (RCT) design is needed in which one group undergoes mammography and the other group undergoes mammography and MR imaging. With this design, it is possible to determine the proportion of interval cancers within each study arm. For this to be an effective screening strategy, the additional cancers detected at MR imaging screening must be accompanied by a subsequent reduction in interval cancers. The Dense Tissue and Early Breast Neoplasm Screening, or DENSE, trial is a multicenter RCT performed in the Dutch biennial population-based screening program (subject age range, 50-75 years). The study was approved by the Dutch Minister of Health, Welfare and Sport. In this study, mammographic density is measured by using a fully automated volumetric method. Participants with extremely dense breasts (American College of Radiology breast density category 4) and a negative result at mammography (Breast Imaging Recording and Data System category 1 or 2) are randomly assigned to undergo additional MR imaging (n = 7237) or to be treated according to current practice (n = 28 948). Participants provide written informed consent before the MR imaging examination, which consists of dynamic breast MR imaging with gadolinium-based contrast medium and is intended to be performed for three consecutive screening rounds. The primary outcome is the difference in the proportions of interval cancers between the study arms. Secondary outcomes are the number of MR imaging screening-detected cancers, proportions of false-positive results, diagnostic yield of MR imaging, tumor characteristics, quality of life, and cost effectiveness.

The added diagnostic value of dynamic contrast-enhanced MRI at 3.0 T in nonpalpable breast lesions.

OBJECTIVE: To investigate the added diagnostic value of 3.0 Tesla breast MRI over conventional breast imaging in the diagnosis of in situ and invasive breast cancer and to explore the role of routine versus expert reading. MATERIALS AND METHODS: We evaluated MRI scans of patients with nonpalpable BI-RADS 3-5 lesions who underwent dynamic contrast-enhanced 3.0 Tesla breast MRI. Initially, MRI scans were read by radiologists in a routine clinical setting. All histologically confirmed index lesions were re-evaluated by two dedicated breast radiologists. Sensitivity and specificity for the three MRI readings were determined, and the diagnostic value of breast MRI in addition to conventional imaging was assessed. Interobserver reliability between the three readings was evaluated. RESULTS: MRI examinations of 207 patients were analyzed. Seventy-eight of 207 (37.7%) patients had a malignant lesion, of which 33 (42.3%) patients had pure DCIS and 45 (57.7%) invasive breast cancer. Sensitivity of breast MRI was 66.7% during routine, and 89.3% and 94.7% during expert reading. Specificity was 77.5% in the routine setting, and 61.0% and 33.3% during expert reading. In the routine setting, MRI provided additional diagnostic information over clinical information and conventional imaging, as the Area Under the ROC Curve increased from 0.76 to 0.81. Expert MRI reading was associated with a stronger improvement of the AUC to 0.87. Interobserver reliability between the three MRI readings was fair and moderate. CONCLUSIONS: 3.0 T breast MRI of nonpalpable breast lesions is of added diagnostic value for the diagnosis of in situ and invasive breast cancer.

Radiofrequency-assisted intact specimen biopsy of breast tumors: critical evaluation according to the IDEAL recommendations.

Radiofrequency-assisted intact specimen biopsy (RFIB) has been introduced for percutaneous biopsy or removal of breast tumors. Using radiofrequency cutting, the system enables the radiologist to obtain an intact sample of the target lesion. According to the IDEAL recommendations, we performed a critical evaluation of our initial experience with RFIB. Between June and November 2010, radiography-guided RFIB was performed in 19 female patients. All patients presented with suspicious microcalcifications (BI-RADS III-V) on mammography. Biopsy specimen integrity, thermal damage and histologic diagnosis were assessed by an expert breast pathologist. Data on technical success, diagnostic and therapeutic accuracy and periprocedural complications were collected and analyzed. The median age of the patients was 59 years. Median lesion diameter on mammography was 8 mm (range 2-76 mm). The procedure was successful in 16/19 (84%) patients and unsuccessful in 3/19 (16%) patients (2 non-representative samples, 1 sample with extensive thermal damage). Histologic analysis of the RFIB specimen revealed 12/19 (63%) benign lesions and 7/19 (37%) malignancies (4 ductal carcinoma in situ (DCIS) lesions and 3 invasive ductal carcinomas). In 1 patient, a DCIS lesion was completely removed with RFIB. Overall, 3 periprocedural complications occurred (1 wound leakage, 1 arterial hemorrhage and 1 infection requiring oral antibiotics). Tissue sampling of suspicious breast lesions can be performed successfully with RFIB. In 1 patient DCIS was radically excised with RFIB, which illustrates its potential as a minimally invasive therapeutic procedure for removal of small breast tumors. This is an interesting focus for further research when larger probe sizes become available.