Microwave imaging for breast cancer screening: protocol for an open, multicentric, interventional, prospective, non-randomised clinical investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries.

Introduction: Microwave imaging presents several potential advantages including its non-ionising and harmless nature. This open, multicentric, interventional, prospective, non-randomised trial aims to validate MammoWave's artificial intelligence (AI)-based classification algorithm, leveraging microwave imaging, to achieve a sensitivity exceeding 75% and a specificity exceeding 90% in breast screening.

Methods And Analysis: 10 000 volunteers undergoing regular mammographic breast cancer screening will be recruited across 9 European centres and invited to participate in the clinical study, involving MammoWave testing on both breasts.

Radiomic and clinical model for predicting atypical ductal hyperplasia upgrades and potentially reduce unnecessary surgical treatments.

Objective: To identify patients with atypical ductal hyperplasia (ADH) at low risk of upgrading to carcinoma. This study aims to assess the performance of radiomics combined with clinical factors to predict occult breast cancer among women diagnosed with ADH.

Methods: This study retrospectively included microcalcification clusters of patients who underwent Mx and VABB with a diagnosis of ADH at a tertiary center from January 2015 to May 2023.

Budget impact analysis of introducing digital breast tomosynthesis in breast cancer screening in Italy.

Purpose: This study quantifies the impact on budget and cost per health benefit of implementing digital breast tomosynthesis (DBT) in place of digital mammography (DM) for breast cancer screening among asymptomatic women in Italy.

Methods: A budget impact analysis and a cost consequence analysis were conducted using parameters from the MAITA project and literature. The study considered four scenarios for DBT implementation, i.

Organizational impact of systemic implementation of digital breast tomosynthesis as a primary test for breast cancer screening in Italy.

Purpose: We present a comprehensive investigation into the organizational, social, and ethical impact of implementing digital breast tomosynthesis (DBT) as a primary test for breast cancer screening in Italy. The analyses aimed to assess the feasibility of DBT specifically for all women aged 45-74, women aged 45-49 only, or those with dense breasts only.

Methods: Questions were framed according to the European Network of Health Technology Assessment (EuNetHTA) Screening Core Model to produce evidence for the resources, equity, acceptability, and feasibility domains of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) decision framework.

Long-term outcome of 9G MRI-guided vacuum-assisted breast biopsy: results of 293 single-center procedures and underestimation rate of high-risk lesions over 12 years.

Purpose: Breast magnetic resonance imaging (MRI) can detect some malignant lesions that are not visible on mammography (MX) or ultrasound (US). If a targeted, second-look fails, MRI-guided breast biopsy is the only available tool to obtain a tissue sample and pathological proof of these "MRI-only lesions". The aim of this study is to report the performance and underestimation rate of 9G MRI-guided vacuum-assisted breast biopsy (VABB) over 12 years at a single center.

A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave's ability in breast lesions detection.

Microwave imaging is a safe and promising new technology in breast radiology, avoiding discomfort of breast compression and usage of ionizing radiation. This paper presents the first prospective microwave breast imaging study during which both symptomatic and asymptomatic subjects were recruited. Specifically, a prospective multicentre international clinical trial was performed in 2020-2021, to investigate the capability of a microwave imaging device (MammoWave) in allowing distinction between breasts with no radiological finding (NF) and breasts with radiological findings (WF), i.

A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection.

Novel techniques, such as microwave imaging, have been implemented in different prototypes and are under clinical validation, especially for breast cancer detection, due to their harmless technology and possible clinical advantages over conventional imaging techniques. In the prospective study presented in this work, we aim to investigate through a multicentric European clinical trial (ClinicalTrials.gov Identifier NCT05300464) the effectiveness of the MammoWave microwave imaging device, which uses a Huygens-principle-based radar algorithm for image reconstruction and comprises dedicated image analysis software.

Complete pathological response of hormone receptor positive invasive breast cancer in a patient with multiple myeloma treated with ixazomib.

Multiple myeloma is a hematological cancer characterized by relapse after treatment and poor prognosis. Ixazomib, a second-generation protease inhibitor, is one of the most recently available treatments for relapsed or refractory multiple myeloma, while it has also shown good potential as antitumoral agent in preclinical solid tumor models such as breast cancer cell lines. Here we report the case of a 68-year-old female with multiple myeloma and an incidental cT1b (9 mm) hormone receptor positive breast cancer lesion that showed a complete pathological response to a three-month combination therapy with Ixazomib, bendamustine and dexamethasone and no signs of disease relapse during the later follow-up.

Triple-negative Breast Cancer Arising in a Fibroadenoma in BRCA 1 Mutated Patient.

We describe the case of a 35-year-old woman who comes to our institute with a palpable lump on her left breast. Clinically the mass was mobile, nontender and with no nipple discharge. Sonography revealed a circumscribed, oval-shaped, and hypoechoic mass, suggestive of a benign lesion.

Screening and diagnostic breast MRI: how do they impact surgical treatment? Insights from the MIPA study.

Objectives: To report mastectomy and reoperation rates in women who had breast MRI for screening (S-MRI subgroup) or diagnostic (D-MRI subgroup) purposes, using multivariable analysis for investigating the role of MRI referral/nonreferral and other covariates in driving surgical outcomes.

Methods: The MIPA observational study enrolled women aged 18-80 years with newly diagnosed breast cancer destined to have surgery as the primary treatment, in 27 centres worldwide. Mastectomy and reoperation rates were compared using non-parametric tests and multivariable analysis.

Freehand 1.5T MR-Guided Vacuum-Assisted Breast Biopsy (MR-VABB): Contribution of Radiomics to the Differentiation of Benign and Malignant Lesions.

Radiomics and artificial intelligence have been increasingly applied in breast MRI. However, the advantages of using radiomics to evaluate lesions amenable to MR-guided vacuum-assisted breast biopsy (MR-VABB) are unclear. This study includes patients scheduled for MR-VABB, corresponding to subjects with MRI-only visible lesions, i.

Standard Operating Procedures (SOPs) for non-invasive multiple biomarkers detection in an academic setting: A critical review of the literature for the RENOVATE study protocol.

Liquid biopsy has the potential to drastically change clinical practice, paving the way to a novel non-invasive approach for cancer diagnosis and treatment. One of the limitations for the implementation of liquid biopsy in clinical practice is the lack of shared and reproducible standard operating procedures (SOPs) for sample collection, processing and storage. Here, we present a critical review of the literature focusing on the available SOPs to guide liquid biopsy management in research settings and describe SOPs that our laboratory developed and employed in the context of a prospective clinical-translational trial (RENOVATE, NCT04781062).

Is 9-G DBT-Guided Vacuum-Assisted Breast Biopsy Sufficient to Completely Remove T1 Breast Cancers (below 20 mm)? Analysis of 146 Patients with Histology as Reference Standard.

Objectives: Vacuum-assisted breast biopsy (VABB) is a safe procedure comparable to surgical biopsy for the characterization of distortions, microcalcifications, and mass lesions. Vacuum-assisted excision of T1 breast tumors could be on potential management in alternative to surgery. The primary objective of this work was to assess the therapeutic success of the stereotaxic vacuum breast biopsy in small breast cancer (T1N0M0) lesions excision.

Artificial Intelligence in Breast Ultrasound: From Diagnosis to Prognosis-A Rapid Review.

Background: Ultrasound (US) is a fundamental diagnostic tool in breast imaging. However, US remains an operator-dependent examination. Research into and the application of artificial intelligence (AI) in breast US are increasing.

Muscle mass loss in breast cancer patients of reproductive age (≤ 45 years) undergoing neoadjuvant chemotherapy.

Purpose: Loss of muscle mass is associated with negative clinical outcome in breast cancer (BC) patients. Therefore, the aim of the study is to evaluate if there is pectoralis muscle area (PMA) depletion, reflecting loss of muscle mass, in breast cancer patients of reproductive age (≤ 45 years) undergoing neoadjuvant chemotherapy (NAC) and to correlate PMA with clinical and histopathological data.

Material And Methods: This monocentric study, approved by our institutional review board, enrolled a total of 52 consecutive patients (mean age 37 ± 4.

PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology.

Background: Approximately 5-10% of unselected breast cancer (BC) patients retain a hereditary predisposition related to a germline mutation in BRCA1/2 genes. The poly-ADP ribose polymerase (PARP)-inhibitors olaparib and talazoparib have been granted marketing authorization by both FDA and EMA for adults with BRCA1/2 germline mutations and HER2-negative (HER2-) advanced BC based on the results from the phase III OlympiAd and EMBRACA trials.

Methods: The panel of the Italian Association of Medical Oncology (AIOM) Clinical Practice Guidelines on Breast Cancer addressed two critical clinical questions, adopting the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach and the Evidence to Decision framework (EtD), to develop recommendations on the use of PARP-inhibitors, with respect to single-agent chemotherapy, in patients with BRCA-related triple-negative (clinical question 1) and hormone receptor-positive (HR+)/HER2- (clinical question 2) advanced BC.

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

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.

Provision of follow-up care for women with a history of breast cancer following the 2016 position paper by the Italian Group for Mammographic Screening and the Italian College of Breast Radiologists by SIRM: a survey of Senonetwork Italian breast centres.

Introduction: In 2016, the Italian Group for Mammography Screening and the Italian College of Breast Radiologists by the Italian Society of Medical and Interventional Radiology recommended that screening programmes and specialist breast centres actively invite women with a history of breast cancer to follow-up imaging.

Objective: A survey of breast centres associated with Senonetwork, the Italian network of breast cancer services, has offered the opportunity to assess the implementation of this recommendation.

Methods: A national, cross-sectional, voluntary, online survey was developed, pre-tested, and administered during the months July-October 2020.

Structured reporting of x-ray mammography in the first diagnosis of breast cancer: a Delphi consensus proposal.

Background: Radiology is an essential tool in the management of a patient. The aim of this manuscript was to build structured report (SR) Mammography based in Breast Cancer.

Methods: A working team of 16 experts (group A) was composed to create a SR for Mammography Breast Cancer.

Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol.

Introduction: Standard procedures aimed at the early diagnosis of breast cancer (BC) present suboptimal accuracy and imply the execution of invasive and sometimes unnecessary tissue biopsies. The assessment of circulating biomarkers for diagnostic purposes, together with radiomics, is of great potential in BC management.

Methods And Analysis: This is a prospective translational study investigating the accuracy of the combined assessment of multiple circulating analytes together with radiomic variables for early BC diagnosis.

Magnetic resonance imaging before breast cancer surgery: results of an observational multicenter international prospective analysis (MIPA).

Objectives: Preoperative breast magnetic resonance imaging (MRI) can inform surgical planning but might cause overtreatment by increasing the mastectomy rate. The Multicenter International Prospective Analysis (MIPA) study investigated this controversial issue.

Methods: This observational study enrolled women aged 18-80 years with biopsy-proven breast cancer, who underwent MRI in addition to conventional imaging (mammography and/or breast ultrasonography) or conventional imaging alone before surgery as routine practice at 27 centers.

MRI versus Mammography plus Ultrasound in Women at Intermediate Breast Cancer Risk: Study Design and Protocol of the MRIB Multicenter, Randomized, Controlled Trial.

In women at high/intermediate lifetime risk of breast cancer (BC-LTR), contrast-enhanced magnetic resonance imaging (MRI) added to mammography ± ultrasound (MX ± US) increases sensitivity but decreases specificity. Screening with MRI alone is an alternative and potentially more cost-effective strategy. Here, we describe the study protocol and the characteristics of enrolled patients for MRIB feasibility, multicenter, randomized, controlled trial, which aims to compare MRI alone versus MX+US in women at intermediate breast cancer risk (aged 40-59, with a 15-30% BC-LTR and/or extremely dense breasts).

Mammography self-evaluation online test for screening readers: an Italian Society of Medical Radiology (SIRM) initiative.

Objectives: To report and analyse the characteristics and performance of the first cohort of Italian radiologists completing the national mammography self-evaluation online test established by the Italian Society of Medical Radiology (SIRM).

Methods: A specifically-built dataset of 132 mammograms (24 with screen-detected cancers and 108 negative cases) was preliminarily tested on 48 radiologists to define pass thresholds (62% sensitivity and 86% specificity) and subsequently made available online to SIRM members during a 13-month timeframe between 2018 and 2019. Associations between participants' characteristics, pass rates, and diagnostic accuracy were then investigated with descriptive statistics and univariate and multivariable regression analyses.