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

Completed

Conditions: breast lesion
breast tumor
10006291

Registration Number: NL-OMON43355

Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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

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
No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) To assess whether ultrasonically visualized breast lesions, categorized as<br /><br>BI-RADS® 4a, with a VTIQ-measured shear velocity value of smaller than or equal<br /><br>to 3.5 m/s (37 kPa), show a lower malignancy rate than BI-RADS® 4a with a<br /><br>VTIQ-measured shear velocity value of larger than 3.5 m/s (37 kPa).<br /><br><br /><br>2) To assess whether the malignancy rate of ultrasonically visualized breast<br /><br>lesions categorized as BI-RADS® 4a with a VTIQ-measured shear velocity value of<br /><br>smaller than or equal to 3.5 m/s (37 kPa) is below 2%.<br /><br><br /><br>3) To assess whether the malignancy rate of ultrasonically visualized breast<br /><br>lesions categorized as BI-RADS® 3 with a VTIQ-measured shear velocity value of<br /><br>smaller than or equal to 3.5 m/s (37 kPa) is below 2%.</p><br>

Secondary Outcome Measures