Dataset related to "A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection"

  • Gianluigi Tiberi (Creator)
  • Mohammad Ghavami (Contributor)
  • Daniel Alvarez Sánchez-Bayuela (Contributor)
  • Navid Ghavami (Contributor)
  • A Tagliafico (Contributor)
  • C Romero Castellano (Contributor)

Dataset

Description

Microwave imaging is a safe and promising new technology in breast radiology, avoiding discomfort of breast compression and usage of ionizing radiation. This dataset relates to a paper which 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.e., with benign or malignant lesions. Each breast scan was performed with the volunteers lying on a dedicated examination table in a comfortable prone position. MammoWave output was compared to reference standard (i.e., radiologic study obtained within the last month and integrated with histological one if available and deemed necessary by responsible investigator) to classify breasts into NF/WF categories. MammoWave output consists of a selection of microwave images’ features (determined prior to trials’ start), which allow distinction between NF and WF breasts (using statistical significance p<0.05). 353 women were enrolled in the study (mean age 51 years ± 12 [SD], minimum age 19, maximum age 78); MammoWave data from the first 15 women of each site, all with NF breasts, were used for calibration. Following central assessor evaluation, 111 NF (48 dense) and 272 WF (136 dense) breasts were used for comparison with MammoWave output. 272 WF comprised 182 benign findings and 90 malignant histology-confirmed cancer. A sensitivity of 82.3% was achieved (95%CI: 0.78-0.87); sensitivity is maintained when limiting the investigation to histology-confirmed breasts cancer only (90 histology-confirmed breasts cancer have been included in this analysis, having sizes ranging from 3 mm to 60 mm). Specificity value of approximately 50% was achieved as expected, since thresholds were calculated (for each feature) using median value obtained after recruiting the first 15 women (of each site), all NF. This prospective trial may represent another step for introducing microwave imaging into clinical practice, for helping in breast lesion identification in asymptomatic women.
Date made available29 Jun 2023
Date of data production1 Jan 2020 - 1 Jan 2022

Keywords for datasets

  • Keyword
  • Microwave breast imaging
  • breast cancer detection
  • breast cancer screening

Data Collection Method

  • Description
  • The data was collected during a clinical trial conducted in Italy by a company (UBT) during a H2020 project. ClinicalTrials.gov Identifier: NCT04253366

Data preparation and processing activities

  • Description
  • Please refer to the paper: ""A multicentric, single arm, prospective, stratified clinical investigation to evaluate MammoWave’s ability in breast lesions detection"" All data have been anonymized with only the staff who took the data aware of patients details. Specifically, information that identifies an individual patient has been removed and replaced by a digit ID number code.

Statement on legal, ethical, and access issues:

  • Description
  • Three hospitals (2 in Italy and 1 in Spain) took part in this study, after obtaining the approvals from the correspondent Ethical Committees (ID: 2558; ID: 262/2019; ID: 440). The study was carried out in accordance with the protocol and principles of Declaration of Helsinki and the guidelines of Good Clinical Practice issued by ICH. All subjects included in the study consented to participate.

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