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A Prospective Comparative Evaluation of Handheld Ultrasound Examination (HHUS) or Automated Ultrasound Examination (ABVS) in Women with Dense Breast.

ABSTRACT: Mammography is the gold standard examination for breast cancer screening. In women with high breast density, mammography has reduced sensitivity. In these women, an additional screening option is often recommended. This study prospectively compared ABVS and HHUS in women with mammography-negative examinations and dense breasts. Materials and methods: N = 222 women were evaluated prospectively and consecutively between January 2019 and June 2019 (average age 53 years; range 39−89). McNemar’s test and ROC analysis were used with standard statistical software. We included in the study both symptomatic and asymptomatic women with dense breasts. Women included underwent both HHUS and ABVS after mammography with independent reading. Results: N = 33/222 (15%) women resulted in having breast cancer. Both ABVS and HHUS identified more cancers than standard mammography, and both HHUS and ABVS had false-positive examinations: n = 13 for HHUS and n = 12 for ABVS. We found that HHUS had better accuracy than ABVS. The AUC of the ROC was 0.788 (95% CI 0.687−0.890) for ABVS and 0.930 (95% CI 0.868−0.993) for HHUS. This difference was statistically significant (p < 0.05). Conclusions: HHUS was more accurate in breast cancer detection than ABVS. Multicentric studies must confirm these data for supplemental imaging in women with dense breasts.

SUBMITTER: Brunetti N

PROVIDER: S-EPMC9497758 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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A Prospective Comparative Evaluation of Handheld Ultrasound Examination (HHUS) or Automated Ultrasound Examination (ABVS) in Women with Dense Breast.

Brunetti Nicole N De Giorgis Sara S Tosto Simona S Garlaschi Alessandro A Rescinito Giuseppe G Massa Barbara B Calabrese Massimo M Tagliafico Alberto Stefano AS

Diagnostics (Basel, Switzerland) 20220908 9

Mammography is the gold standard examination for breast cancer screening. In women with high breast density, mammography has reduced sensitivity. In these women, an additional screening option is often recommended. This study prospectively compared ABVS and HHUS in women with mammography-negative examinations and dense breasts. Materials and methods: N = 222 women were evaluated prospectively and consecutively between January 2019 and June 2019 (average age 53 years; range 39−89). McNemar’s test ...[more]

PMID: 36140571

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Project description:ObjectiveAutomated breast ultrasound (ABUS) is a relevant imaging technique for early breast cancer diagnosis and is increasingly being used as a supplementary tool for mammography. This study compared the performance of ABUS and handheld ultrasound (HHUS) in detecting and characterizing the axillary lymph nodes (LNs) in patients with breast cancer.Materials and methodsWe retrospectively reviewed the medical records of women with recently diagnosed early breast cancer (≤ T2) who underwent both ABUS and HHUS examinations for axilla (September 2017-May 2018). ABUS and HHUS findings were compared using pathological outcomes as reference standards. Diagnostic performance in predicting any axillary LN metastasis and heavy nodal-burden metastases (i.e., ≥ 3 LNs) was evaluated. The ABUS-HHUS agreement for visibility and US findings was calculated.ResultsThe study included 377 women (53.1 ± 11.1 years). Among 385 breast cancers in 377 patients, 101 had axillary LN metastases and 30 had heavy nodal burden metastases. ABUS identified benign-looking or suspicious axillary LNs (average, 1.4 ± 0.8) in 246 axillae (63.9%, 246/385). According to the per-breast analysis, the sensitivity, specificity, positive and negative predictive values, and accuracy of ABUS in predicting axillary LN metastases were 43.6% (44/101), 95.1% (270/284), 75.9% (44/58), 82.6% (270/327), and 81.6% (314/385), respectively. The corresponding results for HHUS were 41.6% (42/101), 95.1% (270/284), 75.0% (42/56), 82.1% (270/329), and 81.0% (312/385), respectively, which were not significantly different from those of ABUS (P ≥ 0.53). The performance results for heavy nodal-burden metastases were 70.0% (21/30), 89.6% (318/355), 36.2% (21/58), 97.3% (318/327), and 88.1% (339/385), respectively, for ABUS and 66.7% (20/30), 89.9% (319/355), 35.7% (20/56), 97.0% (319/329), and 88.1% (339/385), respectively, for HHUS, also not showing significant difference (P ≥ 0.57). The ABUS-HHUS agreement was 95.9% (236/246; Cohen's kappa = 0.883).ConclusionAlthough ABUS showed limited sensitivity in diagnosing axillary LN metastasis in early breast cancer, it was still useful as the performance was comparable to that of HHUS.

Project description:BackgroundThe iBreastExam electronically palpates the breast to identify possible abnormalities. We assessed the iBreastExam performance compared with clinical breast examination for breast lesion detection in high risk and symptomatic Nigerian women.MethodsThis prospective study was done at the Obafemi Awolowo University Teaching Hospital Complex (OAUTHC) in Nigeria. Participants were Nigerian women aged 40 years or older who were symptomatic and presented with breast cancer symptoms or those at high risk with a first-degree relative who had a history of breast cancer. Participants underwent four breast examinations: clinical breast examination (by an experienced surgeon), the iBreastExam (performed by recent nursing school graduates, who finished nursing school within the previous year), ultrasound, and mammography. Sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of the iBreastExam and clinical breast examination for detecting any breast lesion and suspicious breast lesions were calculated, using mammography and ultrasound as the reference standard.FindingsBetween June 19 and Dec 5, 2019, 424 Nigerian women were enrolled (151 [36%] at high risk of breast cancer and 273 [64%] symptomatic women). The median age of participants was 46 years (IQR 42-52). 419 (99%) women had a breast imaging-reporting and data system (BI-RADS) assessment and were included in the analysis. For any breast finding, the iBreastExam showed significantly better sensitivity than clinical breast examination (63%, 95% CI 57-69 vs 31%, 25-37; p<0·0001), and clinical breast examination showed significantly better specificity (94%, 90-97 vs 59%, 52-66; p<0·0001). For suspicious breast findings, the iBreastExam showed similar sensitivity to clinical breast examination (86%, 95% CI 70-95 vs 83%, 67-94; p=0·65), and clinical breast examination showed significantly better specificity (50%, 45-55 vs 86%, 83-90; p<0·0001). The iBreastExam and clinical breast examination showed similar NPVs for any breast finding (56%, 49-63 vs 52%, 46-57; p=0·080) and suspicious findings (98%, 94-99 vs 98%, 96-99; p=0·42), whereas the PPV was significantly higher for clinical breast examination in any breast finding (87%, 77-93 vs 66%, 59-72; p<0·0001) and suspicious findings (37%, 26-48 vs 14%, 10-19; p=0·0020). Of 15 biopsy-confirmed cancers, clinical breast examination and the iBreastExam detected an ipsilateral breast abnormality in 13 (87%) women and missed the same two cancers (both <2 cm).InterpretationThe iBreastExam by nurses showed a high sensitivity and NPV, but lower specificity than surgeon's clinical breast examination for identifying suspicious breast lesions. In locations with few experienced practitioners, the iBreastExam might provide a high sensitivity breast evaluation tool. Further research into improved specificity with device updates and cost feasibility in low-resource settings is warranted.FundingPrevent Cancer Foundation Global Community Grant Award with additional support from the P30 Cancer Center Support Grant (P30 CA008748).

Project description:BackgroundMammographic screening alone will miss a certain fraction of malignancies, as evidenced by retrospective reviews of mammograms following a subsequent screening. Mammographic breast density is a marker for increased breast cancer risk and is associated with a higher risk of interval breast cancer, i.e. cancer detected between screening tests. The purpose of this review is to estimate risks and benefits of supplemental breast ultrasound in women with negative mammographic screening with dense breast tissue.MethodsA systematic search and review of studies involving mammography and breast ultrasound for screening of breast cancer was conducted. The search was performed for the period 1/2000-8/2008 within the data source of PubMed, DARE, and Cochrane databases. Inclusion and exclusion criteria were determined prospectively, and the Oxford evidence classification system for diagnostic studies was used for evidence level. The parameters biopsy rate, positive predictive value (PPV) for biopsy, cancer yield for breast ultrasound alone, and carcinoma detection rate by breast density were extracted or constructed.ResultsThe systematic search identified no randomized controlled trials or systematic reviews, six cohort studies of intermediate level of evidence (3b) were found. Only two of the studies included adequate follow-up of subjects with negative or benign findings. Supplemental breast ultrasound after negative mammographic screening permitted diagnosis of primarily invasive carcinomas in 0.32% of women in breast density type categories 2-4 of the American College of Radiology (ACR); mean tumor size for those identified was 9.9 mm, 90% with negative lymph node status. Most detected cancers occurred in mammographically dense breast ACR types 3 and 4. Biopsy rates were in the range 2.3%-4.7%, with PPV of 8.4-13.7% for those biopsied due to positive ultrasound, or about one third of the PPV of biopsies due to mammography.LimitationsThe study populations included wide age ranges, and the application to women age 50-69 years as proposed for mammographic screening could result in less striking benefit. Further validation studies should employ a uniform assessment system such as BI-RADS and report not only PPV, but also negative predictive value, sensitivity and specificity.ConclusionSupplemental breast ultrasound in the population of women with mammographically dense breast tissue (ACR 3 and 4) permits detection of small, otherwise occult, breast cancers. Potential adverse impacts for women in this intermediate risk group are associated with an increased biopsy rate.

Project description:IntroductionThe technical development of ultrasound devices based on silicon chips has revolutionized ultrasound examinations, leading to the implementation of these portable handheld devices (PUD) in different medical fields. However, training on these devices is necessary to assure appropriate use and ensure valid results. While training programs for the use of conventional standard ultrasound devices (SUD) have been described, no training program for these handheld devices has been developed thus far.MethodsA training program for obstetric ultrasound examination was modified through the addition of an extra module focusing on the use of these PUDs. After the module the students had to attend an OSCE in which their skills of using the PUD and the SUD were tested and analyzed by applying the agreement rate, the intraclass correlation coefficient (ICC) and Bland-Altman plots. Furthermore, the students' ultrasound results were compared with those of trained physicians by employing the one-sample Student's t-test. After the OSCE, the students answered a survey regarding their experience and their expected use of these devices.ResultAn agreement of one hundred percent was reached for basic parameters such as fetal position, placental position, fetal heartbeat and for the classification of the amniotic fluid. The ICC showed a good to moderate agreement between the results of fetal biometry achieved by SUD and PUD. The T-test results confirmed a high reliability between the physicians' results and the students' results, independent of the used device. The students remarked a good handling of the ultrasound devices and supported the use in their future specialties.DiscussionThe reliability between the examinations using the SUD and PUD were high but lower than the results observed for trained physicians. Therefore, the implementation of an additional module for portable ultrasound teaches the students to reliably examine basic obstetric parameters and provides a solid basis for further training and improvement of ultrasound skills in use of PUD.

Dataset Information

A Prospective Comparative Evaluation of Handheld Ultrasound Examination (HHUS) or Automated Ultrasound Examination (ABVS) in Women with Dense Breast.

Publications

A Prospective Comparative Evaluation of Handheld Ultrasound Examination (HHUS) or Automated Ultrasound Examination (ABVS) in Women with Dense Breast.

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