3D Ultrasound Breast Imaging | NCT04692818 | Trialant

3D Ultrasound Breast Imaging | NCT04692818 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clinically indicated breast tumor biopsy	Experimental	Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed	Diagnostic Test: GE Logiq E10 clinical ultrasound scanner Diagnostic Test: Verasonics research scanner

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GE Logiq E10 clinical ultrasound scanner	Diagnostic Test	2D B-mode, Doppler, and shear wave elastography images of the lesion	Clinically indicated breast tumor biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BI-RADS Score	BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.	Baseline

Contacts/Locations Module

Condition Browse Module