TRACE4BUS for BI-RADS Classification

NCT ID: NCT06920108

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 590 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-10-31

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

DeepTrace Technologies S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Countries

Italy

Central Contacts

Gianfranco Scaperrotta

Role: CONTACT

Gianfranco.Scaperrotta@istitutotumori.mi.it

+39 333 257 2380

Facility Contacts

Gianfranco Scaperrotta

Role: primary

Gianfranco.Scaperrotta@istitutotumori.mi.it

+39 333 257 2380

Other Identifiers

TRACE4BUSv2.0-CIP-1

Identifier Type: -

Identifier Source: org_study_id