Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions

The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Female
* Age ≥18 years
* Patients with a lesion ≥ 0.5 cm in largest diameter size, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound
* Informed consent about histological examination (core cut biopsy (CCB), vacuum-assisted biopsy (VAB), fine needle aspiration (FNA) or surgery) has already been given in the course of clinical routine
* Signed informed consent of study participation

Exclusion Criteria:

* Pregnant or lactating women
* Women with breast implants on the same side as the lesion
* Women that underwent local radiation or chemotherapy within the last 12 months
* Women with history of breast cancer or breast surgery in the same quadrant
* Lesions in or close to scar tissue (\< 1cm)
* Skin lesions or lesions that have been biopsied previously
* Lesion larger than 4 cm in the longest dimension
* No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.

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