TRACE4BUS for BI-RADS Classification

TRACE4BUS: Use of the TRACE4BUS Software to Support the Physician in Reporting Breast Ultrasound Results According to the International Classification Standard Breast Image - Reporting and Data System (BI-RADS)

The purpose of this clinical study is to evaluate the use of the TRACE4BUS software that is proposed to support the physician in reporting the results of breast ultrasound according to the international classification standard Breast Image - Reporting and Data System (BI-RADS) of the American College of Radiology. This classification is recommended because it reduces the risk of subjective interpretations of descriptive results and prevents these results from being interpreted differently by the physician who evaluated the ultrasound examination, the physician who may have requested the examination, the patient and the patient's trusted physician (family physician or specialist). The BI-RADS classification is based on the evaluation of the shape, size, margins and other characteristics of a possible breast abnormality identified on the ultrasound image by the physician who evaluated the ultrasound examination, characteristics that are not always easy for that physician to evaluate.

The study aims to verify if the BI-RADS classification by the physician can be supported by the TRACE4BUS software. In particular, it refers to the support that the software provides to the physician who has evaluated the ultrasound examination in assigning the BI-RADS category for an abnormality of the breast found to be suspicious by the physician on the basis of qualitative characteristics (shape, size, margins, preferential orientation with respect to the skin plane, internal homogeneity/inhomogeneity, possible acoustic barrier effect, etc.). The TRACE4BUS software, trained on the basis of hundreds of ultrasound images of suspicious breast masses with a certain diagnosis of benignity or malignancy at subsequent diagnostic investigations, performs a quantitative analysis of the ultrasound characteristics of a suspicious breast mass and proposes a BI-RADS category to the physician. In any case, the physician will have complete decision-making power in the final attribution of the BI-RADS category and in the subsequent recommendations or decisions regarding the medical management of the case.

The clinical study also aims to evaluate whether the agreement between physicians in the use of this BI-RADS classification of suspicious breast masses improves with the use of the software.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 590

Contacts and Locations

• Study Contact: Name: Gianfranco Scaperrotta; Phone Number: +39 333 257 2380; Email: Gianfranco.Scaperrotta@istitutotumori.mi.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Contact: Gianfranco Scaperrotta; Phone Number: +39 333 257 2380; Email: Gianfranco.Scaperrotta@istitutotumori.mi.it
      • Contact: Gianfranco Scaperrotta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with breast masses detected at ultrasound imaging and considered suspicious for breast cancer by physicians with experience in breast ultrasound.

Description

Inclusion Criteria:

1. Retrospective study part:

   • Availability of ultrasound-guided breast biopsy and, in case of B3 lesions at needle biopsy, the vacuum-assisted excision, or surgical specimens or a clinical follow-up outcome in at least 12 months subsequent to the biopsy.

2. Prospective study part:

   • Signed informed consent to participate in the study.

Exclusion Criteria:

1. Retrospective study part:

   • Not availability of ultrasound-guided breast biopsy and, in case of B3 lesions at needle biopsy, the vacuum-assisted excision, or surgical specimens, or a clinical follow-up outcome in at least 12 months subsequent to the biopsy. Age < 18 or > 89 years.

2. Prospective study part:

   • Not availability of Signed informed consent to participate in the study. Age < 18 or > 89 years.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective cohort; The investigators propose a retrospective study on patients aged ≥18 years, who have had breast masses detected on ultrasound and considered suspicious for breast cancer by physicians expert in breast ultrasound at the Breast Radiology Unit of the National Cancer Institute, Milan, Italy, from January 1, 2020 to December 31, 2021. These ultrasound images of breast masses will be those acquired in the context of ultrasound-guided core needle biopsy.
Prospective cohort; The investigators propose a prospective design on consecutive patients (age > 18 years) with breast masses detected by ultrasound and considered suspicious for breast cancer by physicians with experience in breast ultrasound at the same clinic, from the approval data of the Ethics Committee until completion of the expected sample size.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity, positive predictive value, sensitivity and negative predictive value	Specificity, positive predictive value, sensitivity and negative predictive value before knowing the BI-RADS category proposed by the TRACE4BUS software and after being informed of the software prediction of BI-RADS category by the TRACE4BUS software.	From enrollment to biopsy up to 12-month follow-up when necessary

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-Cohen	K-Cohen to measure inter-rater agreement between two physicians before knowing the BI-RADS category proposed by the TRACE4BUS software and after being informed of the software prediction of BI-RADS category by the TRACE4BUS software	9 months and 18 months
Number of correct answers on the use of TRACE4BUS as assessed in the training questionnaire	Number of correct answers in the training questionnaire to measure the effectiveness of the training in the use of TRACE4BUS software after one session. More than 70% (0% minimum score, 100% maximum score) of correct answers are required to demonstrate the effectiveness of the training.	From date of training in the use of TRACE4BUS software to the physicians to training efficacy questionnaire within 2 weeks
Total scores on the usability of TRACE4BUS as assessed in the usability satisfaction questionnaire	Total scores on the usability satisfaction questionnaire to measure the usability satisfaction of TRACE4BUS. More than 70% of satisfaction (0% minimum satisfaction, 100% maximum satisfaction) is required to demonstrate the satisfaction on the usability of TRACE4BUS.	9 months and 18 months

Other Outcome Measures

Outcome Measure	Time Frame
Number of software deficiencies, adverse software effects and adverse events for participants	9 months and 18 months

Collaborators and Investigators

• Sponsor: DeepTrace Technologies S.r.l.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Breast ultrasound; BI-RADS classification
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TRACE4BUSv2.0-CIP-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No