TRACE4BUS for BI-RADS Classification

Официальное название

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)

Обзор

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.

Первичные конечные точки

• Specificity, positive predictive value, sensitivity and negative predictive value [Срок оценки: From enrollment to biopsy up to 12-month follow-up when necessary]

Вторичные конечные точки (3)

• K-Cohen [Срок оценки: 9 months and 18 months]
• Number of correct answers on the use of TRACE4BUS as assessed in the training questionnaire [Срок оценки: 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 [Срок оценки: 9 months and 18 months]

Критерии участия

Критерии включения

• 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.
• Prospective study part:

• Signed informed consent to participate in the study.

Критерии исключения

• 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.
• Prospective study part:

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan

Идентификаторы

NCT: NCT06920108 · TRACE4BUSv2.0-CIP-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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