Preliminary study of contrast-enhanced ultrasound in combination with blue dye vs. indocyanine green fluorescence, in combination with blue dye for sentinel lymph node biopsy in breast cancer.

BACKGROUND: This preliminary study aimed to examine the feasibility of sentinel lymph node biopsy (SLNB) using contrast-enhanced ultrasound (CEUS) vs. indocyanine green fluorescence (ICG), combined with blue dye in patients with breast cancer. METHODS: This was a retrospective study of consecutive female patients with invasive stage I-III (based on pre-operative physical examination and imaging) primary breast cancer at the Peking Union Medical College Hospital between 01/2013 and 01/2015 who underwent preoperative SLNB by ICG + blue dye or CEUS + blue dye. The numbers of detected SLNs, detection rates, and recurrence-free survival (RFS) rates were compared between the two groups. RESULTS: A total of 443 patients were included. The detection rates of SLNs in the CEUS + blue dye and ICG + blue dye groups were 98.4 and 98.1%, respectively (P = 0.814). The average numbers of SLNs detected per patient showed no significant difference between the two groups (3.06 ± 1.33 and 3.12 ± 1.31 in the CEUS + blue dye and ICG + blue dye groups, respectively; P = 0.659). After a median follow-up of 46 months, five patients in the CEUS + blue dye group and 15 in the ICG + blue dye group had recurrence. RFS rates showed no significant difference (P = 0.55). CONCLUSION: This preliminary study suggests that CEUS + blue dye and ICG + blue dye are both feasible for SLN detection in breast cancer.

Pitfalls of Contrast Enhanced Ultrasound (CEUS) in determination of breast tumor biological dignity.

The aim of this prospective study was to identify characteristics of breast lesions on contrast enhanced ultrasound (CEUS) that can be a source of diagnostic ambiguity and cause under- or overestimation of examined breast lesions. 215 women (range 23-76 y., mean age 53.16 y) with 215 breast lesions were examined by B-mode ultrasound, followed by CEUS and core biopsy. CEUS parameters: degree of opacification, character of washout and preliminary CEUS result (suspicious, non-suspicious, uncertain) were subsequently correlated with histopathological outcomes. Observed qualitative variables, CEUS results and their analysis with respect to histological type were evaluated using Pearson χ2 square test, p<0.05 was statistically significant. Differences in mean lesion size, mean age of patients, mean size between groups (malignant/benign) with respect to CEUS result were evaluated by t-test. 215 tumors, 116 (53.93%) benign and 99 (46.05%) malignant lesions. 17 (14.66%) benign and 15 (15.15%) malignant lesions expressed atypical washout, 5 (4.31%) benign lesions had early washout and 38 (38.38%) had continuous washout (p<0.0001). 56 (48.28%) benign and 55 (55.56%) malignant lesions had middle degree of opacification, 19 (16.38%) benign had high and 5 (5.05%) malignant lesions low degree of opacification (p<0.0001). Finally, 38 (32.72%) benign and 20 (20.20%) malignant were marked CEUS uncertain. As risk lesions are considered fibroadenomas, fibrocystic lesions, papillomas and low grade DCIS or invasive breast tumors, especially lesions smaller than 10 mm.Identification of CEUS pitfalls with respect to problematic histopathologic entities can reduce the risk of misdiagnosis and improve further management of breast lesions.

Harms of Breast Cancer Screening: Systematic Review to Update the 2009 U.S. Preventive Services Task Force Recommendation.

BACKGROUND: In 2009, the U.S. Preventive Services Task Force recommended biennial mammography screening for women aged 50 to 74 years and selective screening for those aged 40 to 49 years. PURPOSE: To review studies of screening in average-risk women with mammography, magnetic resonance imaging, or ultrasonography that reported on false-positive results, overdiagnosis, anxiety, pain, and radiation exposure. DATA SOURCES: MEDLINE and Cochrane databases through December 2014. STUDY SELECTION: English-language systematic reviews, randomized trials, and observational studies of screening. DATA EXTRACTION: Investigators extracted and confirmed data from studies and dual-rated study quality. Discrepancies were resolved through consensus. DATA SYNTHESIS: Based on 2 studies of U.S. data, 10-year cumulative rates of false-positive mammography results and biopsies were higher with annual than biennial screening (61% vs. 42% and 7% vs. 5%, respectively) and for women aged 40 to 49 years, those with dense breasts, and those using combination hormone therapy. Twenty-nine studies using different methods reported overdiagnosis rates of 0% to 54%; rates from randomized trials were 11% to 22%. Women with false-positive results reported more anxiety, distress, and breast cancer-specific worry, although results varied across 80 observational studies. Thirty-nine observational studies indicated that some women reported pain during mammography (1% to 77%); of these, 11% to 46% declined future screening. Models estimated 2 to 11 screening-related deaths from radiation-induced cancer per 100,000 women using digital mammography, depending on age and screening interval. Five observational studies of tomosynthesis and mammography indicated increased biopsies but reduced recalls compared with mammography alone. LIMITATIONS: Studies of overdiagnosis were highly heterogeneous, and estimates varied depending on the analytic approach. Studies of anxiety and pain used different outcome measures. Radiation exposure was based on models. CONCLUSION: False-positive results are common and are higher for annual screening, younger women, and women with dense breasts. Although overdiagnosis, anxiety, pain, and radiation exposure may cause harm, their effects on individual women are difficult to estimate and vary widely. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts.

BACKGROUND: Many states have laws requiring mammography facilities to tell women with dense breasts and negative results on screening mammography to discuss supplemental screening tests with their providers. The most readily available supplemental screening method is ultrasonography, but little is known about its effectiveness. OBJECTIVE: To evaluate the benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts. DESIGN: Comparative modeling with 3 validated simulation models. DATA SOURCES: Surveillance, Epidemiology, and End Results Program; Breast Cancer Surveillance Consortium; and medical literature. TARGET POPULATION: Contemporary cohort of women eligible for routine screening. TIME HORIZON: Lifetime. PERSPECTIVE: Payer. INTERVENTION: Supplemental ultrasonography screening for women with dense breasts after a negative screening mammography result. OUTCOME MEASURES: Breast cancer deaths averted, quality-adjusted life-years (QALYs) gained, biopsies recommended after a false-positive ultrasonography result, and costs. RESULTS OF BASE-CASE ANALYSIS: Supplemental ultrasonography screening after a negative mammography result for women aged 50 to 74 years with heterogeneously or extremely dense breasts averted 0.36 additional breast cancer deaths (range across models, 0.14 to 0.75), gained 1.7 QALYs (range, 0.9 to 4.7), and resulted in 354 biopsy recommendations after a false-positive ultrasonography result (range, 345 to 421) per 1000 women with dense breasts compared with biennial screening by mammography alone. The cost-effectiveness ratio was $325,000 per QALY gained (range, $112,000 to $766,000). Supplemental ultrasonography screening for only women with extremely dense breasts cost $246,000 per QALY gained (range, $74,000 to $535,000). RESULTS OF SENSITIVITY ANALYSIS: The conclusions were not sensitive to ultrasonography performance characteristics, screening frequency, or starting age. LIMITATION: Provider costs for coordinating supplemental ultrasonography were not considered. CONCLUSION: Supplemental ultrasonography screening for women with dense breasts would substantially increase costs while producing relatively small benefits. PRIMARY FUNDING SOURCE: National Cancer Institute.

Participants' understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START.

BACKGROUND: It is often difficult to enrol healthy volunteers into a randomized controlled trial (RCT) as there are barriers to participants' proper understanding of a trial. This study aimed to evaluate degrees of understanding of the informed consent (IC) process among healthy volunteers who participated in an RCT. Additionally, factors associated with degree of understanding were investigated. METHODS: The J-START (the Japan STrategic Anti-cancer Randomized controlled Trial) is an RCT investigating the effectiveness of ultrasonography screening for breast cancer in women aged 40 to 49 years. To evaluate participants' understanding of the J-START, we administered questionnaires to 376 Japanese women on the day of enrolment at five study sites across Japan. The respondents were asked to complete the anonymous questionnaire within 2 weeks. We assessed objective understanding and perceived subjective understanding of IC using a Japanese version of the Quality of Informed Consent scale (QuIC). Then we analyzed the characteristics of women whose understanding was poor, and clarified the association between providing information and their understanding of the study protocol. RESULTS: The average QuIC scores were 78.2 and 82.2 (out of 100 each) for objective and subjective understanding, respectively. These are generally acceptable scores for participants' understanding of an RCT. However, there were four domains with low scores, indicating poor understanding: (1) experimental nature of the study, (2) potential risks or discomfort, (3) benefit to self, and (4) compensation. CONCLUSIONS: Healthy volunteers generally well understood the J-START. Nevertheless, there were some domains in need of improvement. In order to facilitate participants' understanding, it is necessary to provide training to reduce differences in information-providing procedures between medical centres and to endeavour to provide consistent information and conditions. TRIAL REGISTRATION: The J-START was registered with the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000000757), on July 1, 2007.

Radioactive seed localization with 125I for nonpalpable lesions prior to breast lumpectomy and/or excisional biopsy: methodology, safety, and experience of initial year.

The use of radioactive seed localization (RSL) as an alternative to wire localizations (WL) for nonpalpable breast lesions is rapidly gaining acceptance because of its advantages for both the patient and the surgical staff. This paper examines the initial experience with over 1,200 patients seen at a comprehensive cancer center. Radiation safety procedures for radiology, surgery, and pathology were implemented, and radioactive material inventory control was maintained using an intranet-based program. Surgical probes allowed for discrimination between 125I seed photon energies from 99mTc administered for sentinel node testing. A total of 1,127 patients (median age of 57.2 y) underwent RSL procedures with 1,223 seeds implanted. Implanted seed depth ranged from 10.3-107.8 mm. The median length of time from RSL implant to surgical excision was 2 d. The median 125I activity at time of implant was 3.1 MBq (1.9 to 4.6). The median dose rate from patients with a single seed was 9.5 µSv h-1 and 0.5 µSv h-1 at contact and 1 m, respectively. The maximum contact dose rate was 187 µSv h-1 from a superficially placed seed. RSL performed greater than 1 d before surgery is a viable alternative to WL, allowing flexibility in scheduling, minimizing day of surgery procedures, and improving workflow in breast imaging and surgery. RSL has been shown to be a safe and effective procedure for preoperative localization under mammographic and ultrasound guidance, which can be managed with the use of customized radiation protection controls.

Compliance with screening mammography and breast sonography of young Asian women.

OBJECTIVE: We evaluated compliance with mammography and breast sonography and the factors related to compliance. STUDY DESIGN: From August 2005 through July 2006, 1239 asymptomatic women, aged 40-49 years, were enrolled in the study. Compliance in the second year was calculated. Telephone interviews examined the impact of the women's experience during mammography or sonography on adherence to rescreening. RESULTS: The rates of compliance with mammography and sonography for breast cancer screening were 73.5% and 80.1%, respectively (p=0.006). More women receiving mammography (12.2%) reported unsatisfactory results (BI-RADS category 0) than those undergoing sonography (6.2%) (p<0.001). During the telephone interview, 74.9% of the women complained of pain during mammography, but none (0%) during sonography (p<0.001); 69.8% felt embarrassed during mammography and 55.6% during sonography (p<0.001). Multivariate logistic regression analysis showed that pain (OR 0.096, 95% CI 0.044-0.213) and unsatisfactory examination results (BI-RADS category 0) (OR 0.042, 95% CI 0.020-0.090) were barriers to not following up mammography. Embarrassment (OR 0.645, 95% CI 0.419-0.994) and unsatisfactory examination results (OR 0.169, 95% CI 0.085-0.336) were barriers to not following up sonography. CONCLUSIONS: For young Asian women with dense breast tissue, compliance with sonography for breast cancer screening was better than that with mammography.

[Patient safety in diagnostic ultrasound II--ultrasound guided interventions]. / Patientensicherheit II--Sonographisch geführte Interventionen.

New digital ultrasound techniques simplify the documentation of ultrasound images and allow better comparison with respect to different image modalities. New vascular imaging modes including contrast enhanced power Doppler and 3D power Doppler allow for the detection of very small vessels and leakages. B-flow, a recently introduced digital substraction technique is advancing the detection of residual blood flow in high-grade stenosis without vibration artifacts. Modern contrast agents allow to perform ultrasound guided intervetion such as biopsies and ablation therapies with improved accuracy. This way, the risk for complications can be significantly reduced.

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