Clinical trial NCT06920108: TRACE4BUS for BI-RADS Classification
Official title: 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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Keywords: Breast cancer
BI-RADS classification
Breast ultrasound
Lead sponsor: DeepTrace Technologies S.r.l.
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 590
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


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.

Primary outcomes:
measure: Specificity, positive predictive value, sensitivity and negative predictive value
timeFrame: From enrollment to biopsy up to 12-month follow-up when necessary
Secondary outcomes:
measure: K-Cohen
timeFrame: 9 months and 18 months
measure: Number of correct answers on the use of TRACE4BUS as assessed in the training questionnaire
timeFrame: From date of training in the use of TRACE4BUS software to the physicians to training efficacy questionnaire within 2 weeks
measure: Total scores on the usability of TRACE4BUS as assessed in the usability satisfaction questionnaire
timeFrame: 9 months and 18 months
Other outcomes:
measure: Number of software deficiencies, adverse software effects and adverse events for participants
timeFrame: 9 months and 18 months
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardy
Study officials:
References: