breast lesion breast tumor
Conditions
Interventions
None listed
Sponsors
Jeroen Bosch Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female Age >=18 years Patients with a lesion >= 0.5 cm, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound Signed informed consent of study participation
Exclusion criteria
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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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%. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 pred | — |
Countries
Netherlands
Outcome results
None listed