Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 lesions: Can patient selection for biopsy be improved? - A confirmatory Multi-Center-Study

1) To assess whether ultrasonically visualized breast lesions, categorized as

BI-RADS® 4a, with a VTIQ-measured shear velocity value of smaller than or equal

to 3.5 m/s (37 kPa), show a lower malignancy rate than BI-RADS® 4a with a

VTIQ-measured shear velocity value of larger than 3.5 m/s (37 kPa).



2) To assess whether the malignancy rate of ultrasonically visualized breast

lesions categorized as BI-RADS® 4a with a VTIQ-measured shear velocity value of

smaller than or equal to 3.5 m/s (37 kPa) is below 2%.



3) To assess whether the malignancy rate of ultrasonically visualized breast

lesions categorized as BI-RADS® 3 with a VTIQ-measured shear velocity value of

smaller than or equal to 3.5 m/s (37 kPa) is below 2%.

1) To assess whether ultrasonically visualized breast lesions, categorized as

BI-RADS® 3 with a VTIQ-measured shear velocity value of smaller than or equal

to 3.5 m/s (37 kPa), show a lower malignancy rate than BI-RADS® 3 with a

VTIQ-measured shear velocity value of larger than 3.5 m/s (37 kPa).



2) To assess whether ultrasonically visualized breast lesions, categorized as

BI-RADS® 4b with a VTIQ-measured shear velocity value of smaller than or equal

to 3.5 m/s (37 kPa), show a lower malignancy rate than BI-RADS® 4b with a

VTIQ-measured shear velocity value of larger than 3.5 m/s (37 kPa).





3) To assess whether ultrasonically visualized breast lesions, categorized as

BI-RADS® 4c with a VTIQ-measured shear velocity value of smaller than or equal

to 3.5 m/s (37 kPa), show a lower malignancy rate than BI-RADS® 4c with a

VTIQ-measured shear velocity value of larger than 3.5 m/s (37 kPa).



4) To assess whether the probabilities for malignancies predicted with

ultrasonically visualized breast lesions categorized according to BI-RADS®

differ from the probabilities for malignancies predicted with ultrasonically

visualized breast lesions categorized with the help of VTIQ only or by a

combination of BI-RADS® and VTIQ measurements.





5) To assess whether for women with ultrasonically visualized breast lesions

categorized as BI-RADS® 3, 4a, 4b or 4c, respectively, the subgroup of women

with a strain ratio smaller than or equal to 1 shows a lower malignancy rate

than the subgroup of women with a strain ratio larger than 1.



6) To assess the VTIQ intra-rater reliability for the original continuous scale

and the dichotomized values.





7) To assess, in a subgroup with valid VTIQ results, the reproducibility of

VTIQ shear velocity measurements made on the same lesion in different

examinations performed on the same day by different operators. To assess the

VTIQ inter-rater reliability for the original continuous scale and the

dichotomized values.



8) To assess predictive factors of the continuous VTIQ-value. The following

factors will be examined:

Subject-related factors:

- Skin-breast lesion surface depth (cm)

- Quality factor (color coded scale) within the lesion

- Breast density/ tissue composition (homogeneous background texture fat,

homogeneous background texture fibroglandular, heterogeneous background texture)

- Lesion size in B mode (cm)

- Normal fatty tissue shear wave velocity (Ratio between measurement in the

fatty tissue and in the lesion)

- Pathology and Immunhistology



9) To assess the inter-rater reliability of BI-RADS® Assessment.

Local (BI-RADS® given at each site) and central expert BI-RADS® assessment will

be compared (BI-RADS® assessment and assessment of the variables leading to the

BI-RADS® value separately). In addition, the BI-RADS® assessments will be

compared with the histological results.



10) To examine whether the cut-off value might be increased to further reduce

the number of unnecessary benign biopsies.